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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CALIPER PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH PATELLA CALIPER PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-3-602
Device Problems Crack (1135); Degraded (1153); Peeled/Delaminated (1454); Material Integrity Problem (2978)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Rubber handles are old, peeling, cracked and shedding. Update: issue noticed during sterile procedure or while instrument was cleaning. Not during the regular procedure.

 
Manufacturer Narrative

An event regarding santoprene damage involving a patella caliper was reported. A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there were no similar events for the reported lot. Conclusion: visual inspection showed the device handle has discolored and damaged. The damaged device was discovered during inspection. There was no surgical procedure associated with the reported event. This event meets the definition of preventive maintenance. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Rubber handles are old, peeling, cracked and shedding. Update: issue noticed during sterile procedure or while instrument was cleaning. Not during the regular procedure.

 
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Brand NamePATELLA CALIPER
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5759895
MDR Text Key48787704
Report Number0002249697-2016-02104
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 06/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number6541-3-602
Device LOT NumberSBZK11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/22/2005
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: 06/29/2016 Patient Sequence Number: 1
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