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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 Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Torn Material (3024)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The triathlon saw capture would not snap into the distal femoral cutting block. We opened a new saw capture but it also would not snap into the cutting block. The cutting block has signs of wear and tear.

 
Manufacturer Narrative

An event regarding an assembly issue with a modular saw capture involving a distal resection guide was reported. The event was not confirmed. Method & results: -device evaluation and results: the guide showed signs of scratches on its top surface consistent with its use as a guide for the saw. The device is also found to be functional as it assembled successfully with its mating modular capture. -medical records received and evaluation: not performed because no patient clinical information was provided as there is no evidence to support the event was related to patient factors. -device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other similar events reported for this manufacturing lot. Conclusions: the reported event is not confirmed as the device was found to be functional as it assembled successfully with the modular capture. No further investigation for this event is possible at this time. If additional information becomes available, this investigation will be reopened.

 
Event Description

The triathlon saw capture would not snap into the distal femoral cutting block. We opened a new saw capture but it also would not snap into the cutting block. The cutting block has signs of wear and tear.

 
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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 navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5209621
MDR Text Key31005928
Report Number0002249697-2015-03673
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2015
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 NumberSMM9S00
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/17/2014
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: 11/08/2015 Patient Sequence Number: 1
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