{"id":"a84948e8-9d27-4704-b879-374285fb0394","slug":"stryker-mako-reamer-missing-screw-maude-2025","kind":"malfunction","headline":"Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)","summary":"An FDA MAUDE malfunction report describes a screw missing from a Stryker Mako reamer handle, with X-ray confirming the screws were located outside the operative site; the event occurred twice. Source: FDA MAUDE MDR key 21918326, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","occurredAt":"2025-04-01T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"none","regulatoryBody":"FDA (MAUDE)","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T11:10:33.926Z","updatedAt":"2026-08-09T05:29:22.113Z","model":null,"deployment":null,"company":{"id":"661fbd42-9fcb-4d47-8a74-7a23d161d57b","name":"Stryker","slug":"stryker","description":"Stryker Corporation (NYSE: SYK) is one of the world's largest medical technology companies, headquartered in Kalamazoo, Michigan, with $25B in 2025 revenue and approximately 56,000 employees. The company's Mako SmartRobotics platform is the leading robotic orthopedic surgery system, with record Mako installations in 2024 for hip and knee replacements, and the next-generation Mako showcased at AAOS 2025 including the new Mako Shoulder application.","status":"public (NYSE: SYK)","founded":1941,"hq":"Kalamazoo, MI, USA","hqLat":42.291707,"hqLng":-85.5872286,"hqGeocodedAt":"2026-08-05T14:49:47.923Z","hqAddress":null,"hqPrecision":null,"website":"stryker.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://investors.stryker.com/press-releases/news-details/2013/Stryker-Announces-Definitive-Agreement-to-Acquire-MAKO-Surgical-Corp-for-165-Billion/default.aspx","title":"Stryker to acquire MAKO Surgical for $1.65B ($30/share; announced Sep 25 2013, closed Dec 17 2013)","sourceName":"Stryker Investor Relations"},{"url":"https://www.sec.gov/Archives/edgar/data/0000310764/000031076426000010/syk-20251231.htm","title":"Stryker Form 10-K FY2024: >1M robotic Mako Total Knees + 1.5M total Mako procedures, 45+ countries; 'one of four leading global competitors'","sourceName":"SEC EDGAR"},{"url":"https://investors.stryker.com/press-releases/news-details/2015/Stryker-Receives-FDA-Clearance-For-Mako-Total-Knee-Application/default.aspx","title":"Stryker receives FDA clearance for Mako Total Knee application (Aug 6 2015)","sourceName":"Stryker Investor Relations"}],"keyFacts":[{"label":"Product","value":"Mako SmartRobotics robotic-arm orthopedic system (knee/hip/spine/shoulder)."},{"label":"Boundary","value":"AI-augmented surgeon-controlled assistance, NOT autonomous."},{"label":"Stock ticker","value":"NYSE: SYK"},{"label":"Market position","value":"Mako SmartRobotics is the market-leading robotic-arm system for orthopedic joint replacement"},{"label":"Acquisition","value":"Acquired MAKO Surgical in 2013 for ~$1.65B"},{"label":"CEO","value":"Kevin Lobo (Chair & CEO)"},{"label":"Revenue","value":"$25B (2025)"},{"label":"Stock","value":"NYSE: SYK"},{"label":"Employees","value":"approximately 56,000"},{"label":"Robotics platform","value":"Mako SmartRobotics (hip, knee, shoulder)"},{"label":"Mako platform","value":"Hip, Knee, Spine, Shoulder + Mako RPS handheld (2026)"},{"label":"Mako price","value":"$800,000-$1,400,000 (Mako 4 next-gen)"}],"aliases":["Stryker Corporation","MAKO Surgical","Stryker Corp","Mako","Stryker Mako"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"SYK","stockExchange":"NYSE","secCik":"0000310764","revenueUsd":"25000000000","revenueBasis":"reported","revenueAsOf":"2025-12-31T12:00:00.000Z","employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-04T04:09:25.399Z","updatedAt":"2026-08-05T14:52:25.760Z"},"derived":{"status":"active"},"sources":[{"id":"5f9643c0-a6eb-4e16-96c4-d54bafe8573f","incidentId":"a84948e8-9d27-4704-b879-374285fb0394","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm","label":null,"publishedAt":null,"notes":null,"title":"FDA MAUDE: Stryker Mako reamer missing screw","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:28:31.798Z","updatedAt":"2026-08-09T05:28:31.798Z"},{"id":"eff00d87-bbe5-41ae-bb14-fe2bf9dfd863","incidentId":"a84948e8-9d27-4704-b879-374285fb0394","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21918326&pc=OLO","label":null,"publishedAt":null,"notes":null,"title":"MAUDE Adverse Event Report: STRYKER - Mako reamer handle missing screw during total hip","sourceName":"FDA MAUDE","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T05:31:23.634Z","updatedAt":"2026-08-09T05:31:23.634Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/stryker-mako-reamer-missing-screw-maude-2025","url":"https://registry.deploy.report/incidents/stryker-mako-reamer-missing-screw-maude-2025","headline":"Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)","description":"An FDA MAUDE malfunction report describes a screw missing from a Stryker Mako reamer handle, with X-ray confirming the screws were located outside the operative site; the event occurred twice. Source: FDA MAUDE MDR key 21918326, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.","identifier":"a84948e8-9d27-4704-b879-374285fb0394","datePublished":"2025-04-01T00:00:00.000Z","articleSection":"malfunction","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":2,"primary_source_types":["primary-fda-database"]}}}