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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT ANKLE CLAMP EM INSTRUMENT Back to Search Results
Catalog Number 6541-2-609
Device Problems Clamp (757); Break (1069); Nonstandard Device (1420)
Patient Problem No Patient Involvement (2645)
Event Date 03/30/2015
Event Type  Malfunction  
Event Description

Upon routine inspection of the ankle clamp after sterile processing it was discovered that the clamp was broken.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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 have been similar events for the reported lot. The reported event was confirmed. One of the flippers of the triathlon tibial alignment ankle clamp fractured. The device was manufactured to revision g of the product drawing. 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

Upon routine inspection of the ankle clamp after sterile processing it was discovered that the clamp was broken.

 
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Brand NameTIBIAL ALIGNMENT ANKLE CLAMP EM
Type of DeviceINSTRUMENT
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 navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4719426
MDR Text Key5749520
Report Number0002249697-2015-01330
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number6541-2-609
Device LOT NumberPCZ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received06/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/30/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2249697-7/12/2013-008C

Patient TREATMENT DATA
Date Received: 04/22/2015 Patient Sequence Number: 1
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