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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); Material Integrity Problem (2978)
Patient Problem 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

Noticed that triathlon mis 4:1impactor/extractor was leaving a blue residue on other insts.

 
Manufacturer Narrative

An event regarding alleged "blue residues" involving a mis 4:1 impactor/extractor was reported. The event was not confirmed. Method & results: device evaluation and results: the santoprene handle coating was degraded. However, the blue residue was not apparent. Device history review indicated all devices accepted into stock met specification. Complaint history review indicated there have been no other events associate with the reported lot. Conclusions: visual inspection of the device showed the santoprene handle coating was degraded. However, the blue residue was not apparent. 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

Noticed that triathlon mis 4:1 impactor/extractor was leaving a blue residue on other insts.

 
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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 Key5454719
MDR Text Key38821818
Report Number0002249697-2016-00434
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 01/19/2016
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 Number6541-7-806
Device LOT NumberSB4L25
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/16/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/15/2010
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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