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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH IMPACTION HANDLE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-4-810
Device Problems Degraded (1153); Residue After Decontamination (2325); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 01/19/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

I was called into the room during a tka wile they were opening trays. There was a grease color brown consisting of oil on the instruments with green handles.

 
Manufacturer Narrative

An event regarding alleged santoprene handle degradation involving a triathlon impaction handle was reported. The event was not confirmed. Method & results: device evaluation and results: the device was returned in used condition. Visual inspection indicated that, while the santoprene coating was worn and off color, the device was otherwise clean and appeared in serviceable condition. Oil and/or grease residue was not apparent. 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: conversation with the sales representative indicated oil and/or grease residue was discovered shortly after routine cleaning at the hospital. Visual inspection at stryker orthopaedics indicated that, while the santoprene coating was worn and off color, the device was otherwise clean and appeared in serviceable condition. Oil and/or grease residue was not apparent.

 
Event Description

I was called into the room during a tka wile they were opening trays. There was a grease color brown consisting of oil on the instruments with green handles.

 
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Brand NameIMPACTION HANDLE
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 Key5454739
MDR Text Key38821317
Report Number0002249697-2016-00428
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-4-810
Device LOT NumberCR1N01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/24/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/03/2008
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: 02/23/2016 Patient Sequence Number: 1
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