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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); Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported by sales rep, ankle clamp broke when removing from tibia.

 
Manufacturer Narrative

An event regarding a fractured triathlon tibial alignment ankle clamp was reported. The event was confirmed. Method & results: -devaluation and results: visual analysis confirmed the reported event. One of the device flippers fractured. The device was manufactured to the g revision. -medical records received and evaluation: not performed because there is no indication the event was related to patient factors -device history review: review of the device history records indicated all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been other similar reported event for this lot id. Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use. A capa was raised to document root cause and corrections. Root cause was determined to be design related, the material selected was inadequate for designed use. A material design update was completed and the capa was closed on 10-mar-2014.

 
Event Description

It was reported by sales rep, ankle clamp broke when removing from tibia.

 
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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 Key5081761
MDR Text Key26261138
Report Number0002249697-2015-03037
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-2-609
Device LOT NumberPCZ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/14/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
Was Device Evaluated By Manufacturer? Yes
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: 09/16/2015 Patient Sequence Number: 1
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