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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE DRILL 3.2 MM DIAMETER 30 MM LENGTH INSTRUMENT, HIP

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ZIMMER BIOMET, INC. FLEXIBLE DRILL 3.2 MM DIAMETER 30 MM LENGTH INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 01/08/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Date of birth: unknown month and day in 1967. Report source: foreign: (b)(6). The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that while drilling continuum shell holes the drill broke during use. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameFLEXIBLE DRILL 3.2 MM DIAMETER 30 MM LENGTH
Type of DeviceINSTRUMENT, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9633340
Report Number0001822565-2020-00343
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00661100302
Device LOT Number60976063
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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