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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM

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STRYKER LEIBINGER FREIBURG UNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM Back to Search Results
Model Number 62-32440
Device Problem Fracture
Event Date 12/10/2019
Event Type  Malfunction  
Manufacturer Narrative

The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

 
Event Description

It was reported that the surgeon used a 2. 0mm drill bit to drill the pilot hole for the repositioning pin. The repositioning pin was inserted without problems but when the surgeon was moving the bone, the pin broke leaving the threaded portion in the patient's bone. The surgeon was able to remove the tip from the bone, and the surgery was completed successfully.

 
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Brand NameUNIVERSAL BONE REPOSITIONING INSTRUMENT, DIAM.3.2MM
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE  D-79111
Manufacturer (Section G)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
DE  D-79111
Manufacturer Contact
kelli dykstra
boetzingerstr. 41
freiburg  D-791-11
  D-79111
76145120
MDR Report Key9564000
Report Number0008010177-2020-00001
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number62-32440
Device Catalogue Number62-32440
Device LOT NumberAG10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/14/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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