• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Nonstandard Device (1420); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 04/28/2014
Event Type  Malfunction  
Event Description

Going through some of our trays and noticed clamp was broken on one side. No injuries occurred.

 
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: visual analysis confirmed the reported event. One of the device flippers fractured. The device was manufactured to the f revision. -medical records received and evaluation: not performed because no patient information was provided. In addition, it is believed patient factors did not contribute to the reported event. -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 events for this lot id. Conclusions: the investigation concluded that the ankle clamp flipper broke from multiple overload conditions during use. The exact root cause cannot be determined at this time. Ncr and capa were opened to perform a root cause investigation. Root cause analysis will be documented in the capa file.

 
Event Description

Going through some of our trays and noticed clamp was broken on one side. No injuries occurred.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4841470
MDR Text Key5873372
Report Number0002249697-2015-01899
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,COMPANY REPRESENTATIVE
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/28/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number6541-2-609
Device LOT NumberNZN12
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2005
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: 06/12/2015 Patient Sequence Number: 1
-
-