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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT ANKLE CLAMP EM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT ANKLE CLAMP EM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-2-609
Device Problems Clamp (757); Break (1069); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Ankle clamp broke.

 
Manufacturer Narrative

An event regarding a fractured triathlon tibial alignment ankle clamp was reported. The event was confirmed. Method and results: devaluation and results: visual analysis confirmed the reported event. One of the device flippers fractured. The device was manufactured to the d revision. Medical records received and evaluation: not performed because there is no indication the event was related to patient factors. Device history review: review of the device history records indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been (b)(4) other similar reported events for the lot referenced. Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use. Ncr and capa were opened to address the adverse trend identified for this product and issue. Capa identified the root causes to include insufficient design review procedures at the time of development, insufficient risk analysis, and inadequate material selection. In addition to changing the material, a dfmeca and a risk table were created to properly migitate all potential failure modes.

 
Event Description

Ankle clamp broke.

 
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Brand NameTIBIAL ALIGNMENT ANKLE CLAMP EM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5313980
MDR Text Key34750825
Report Number0002249697-2015-04388
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-2-609
Device LOT NumberNYC03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/18/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2249697-7/12/2013-008C

Patient TREATMENT DATA
Date Received: 12/21/2015 Patient Sequence Number: 1
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