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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 Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2015
Event Type  malfunction  
Event Description
It was reported that, during a preparation of procedure, our sr noticed the broken ankle clamp.The surgeon fixed with some tapes and used it.Our sr said it was broken during a sterilization process because when he checked it before the sterilization, it was not broken yet.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding a fractured triathlon tibial alignment ankle clamp was reported.The event was confirmed.Method & results: device evaluation and results: one of the yokes of the tibial alignment ankle clamp was fractured.The device was manufactured to revision g of the product drawing.-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 indicates all devices accepted into final stock met specifications.-complaint history review: there have been other events for this lot id.Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use.Ncr and capa were opened to perform a root cause investigation.Capa was closed on 10-mar-14.
 
Event Description
It was reported that, during a preparation of procedure, our sr noticed the broken ankle clamp.The surgeon fixed with some tapes and used it.Our sr said it was broken during a sterilization process because when he checked it before the sterilization, it was not broken yet.
 
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Brand Name
TIBIAL ALIGNMENT ANKLE CLAMP EM
Type of Device
INSTRUMENT
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4672328
MDR Text Key5729106
Report Number0002249697-2015-01122
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,health professional,oth
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2015
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 NumberN5L02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2010
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 Sequence Number1
Patient Outcome(s) Other;
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