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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 IMPACTOR/EXTRACTOR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 IMPACTOR/EXTRACTOR PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-7-806
Device Problems Degraded (1153); Residue After Decontamination (2325); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

I had two sets of triathlon instruments that were sterilized for two total knees. We open the first set and found the contaminated handle. We open up the second set and found another contaminated handle. Surgery was delayed and the second case had to be canceled. After separating the handle and sterilizing again for the third time, it again was contaminated with a sticky substance.

 
Manufacturer Narrative

An event regarding alleged "sticky handles" involving a mis 4:1 impactor/extractor was reported. The event was confirmed. Method and results: device evaluation and results: the santoprene handle coating showed signs of degradation and felt sticky. Medical records received and evaluation: not performed because it is believed 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 (b)(4) other events associated with the reported lot. Conclusions: visual inspection of the device showed the santoprene handle showed signs of degradation and felt sticky. A capa was initiated on 20-oct-2010 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

I had two sets of triathlon instruments that were sterilized for two total knees. We open the first set and found the contaminated handle. We open up the second set and found another contaminated handle. Surgery was delayed and the second case had to be canceled. After separating the handle and sterilizing again for the third time, it again was contaminated with a sticky substance.

 
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Brand NameMIS 4:1 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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5505019
MDR Text Key40501075
Report Number0002249697-2016-00848
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 01/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-7-806
Device LOT NumberC2H01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/2007
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: 03/16/2016 Patient Sequence Number: 1
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