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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADED PIN IMPACTOR EXTRACTOR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH HEADED PIN IMPACTOR EXTRACTOR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-4-300
Device Problems Material Disintegration (1177); Delamination (2904); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the handle of the unit appears to be de-laminating. It was reported that the handle feels "gooey. ".

 
Manufacturer Narrative

An event regarding santoprene handle degradation was reported. The event was confirmed. Method & results: device evaluation and results: visual analysis confirmed the reported event. The handle was returned degraded. Medical records received and evaluation: not performed because patient factors did not contribute to the reported event. Device history review indicated all devices accepted into stock met specification. Complaint history review indicated there have been other events associated with the reported lot. Conclusions: capa was initiated because a series of complaints were received for triathlon instrumentation where green santoprene over-mold handles have been reported to be degrading, becoming sticky and unstable. This event was determined to be under the scope of the capa. Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic. The ability to clean and sterilize the degraded instruments has not been compromised.

 
Event Description

It was reported that the handle of the unit appears to be de-laminating. It was reported that the handle feels "gooey".

 
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Brand NameHEADED PIN IMPACTOR EXTRACTOR
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 Key5180153
MDR Text Key29971057
Report Number0002249697-2015-03453
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number6541-4-300
Device LOT NumberN2T18
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/10/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/27/2008
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: 10/27/2015 Patient Sequence Number: 1
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