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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 Crack (1135); Peeled/Delaminated (1454); Insufficient Information (3190)
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

Corrected data: the device was not returned for evaluation. An event regarding santoprene damage involving a triathlon impactor was reported. A visual, functional and dimensional inspection could not be performed as the device was not returned. Conclusion: the event could not be confirmed nor the root cause determined with the limited information provided. If the device or additional information is provided, the investigation will be re opened. Not returned.

 
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 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 Key5759897
MDR Text Key48812799
Report Number0002249697-2016-02115
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 Number6541-7-806
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
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 Received09/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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