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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 Device Inoperable (1663); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that when surgeon opened the tray, it was noticed that the trigger mechanism on the instrument was broken and not functional. Another tray was opened and surgeon used the sam impactor from the new tray. No adverse consequence to patient or user, no surgical delay.

 
Manufacturer Narrative

Reported event: an event regarding dissociating pin involving a triathlon impactor was reported. The received device showed the trigger component dissociated from the device. The event was confirmed. Conclusions: the investigation concluded that the trigger pin dissociation was a result of a previously identified supplier manufacturing nonconformance due to undersized trigger pin diameter. If additional information becomes available, this investigation will be reopened. Product surveillance will continue to monitor for trends. Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

 
Event Description

It was reported that when surgeon opened the tray, it was noticed that the trigger mechanism on the instrument was broken and not functional. Another tray was opened and surgeon used the sam impactor from the new tray. No adverse consequence to patient or user, no surgical delay.

 
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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
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5534428
MDR Text Key41471602
Report Number0002249697-2016-01001
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2016
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 NumberSBZT45
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2006
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: 03/30/2016 Patient Sequence Number: 1
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