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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-1-721
Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Mechanics Altered (2984)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The capture would not lock into the cutting block. Used without capture.

 
Manufacturer Narrative

An event regarding seating/locking issue involving a distal resection guide ¿ standard was reported. The event was not confirmed. Method & results: device evaluation and results: during the function inspection the distal resection guide was able to snap in with the modular capture. The distal resection guide held securely onto the modular capture as intended with no separation trying to pull apart. Medical records received and evaluation: not performed as no medical records were returned for evaluation. Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the exact cause of the event could not be determined because during the functional inspection the distal resection guide was able to snap in with the modular capture. The distal resection guide held securely onto the modular capture as intended with no separation trying to pull apart. The event could not be replicated since the distal resection guide snapped into the modular capture as intended.

 
Event Description

The capture would not lock into the cutting block. Used without capture.

 
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Brand NameDISTAL RESECTION GUIDE - STANDARD
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5808127
MDR Text Key50771938
Report Number0002249697-2016-02383
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
Type of Report Initial,Followup
Report Date 06/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-721
Device LOT NumberC4N02
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/20/2016 Patient Sequence Number: 1
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