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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRHNSVE HYBRID GLEN ST SHNK DRL 15/64 EXTREMITIES, INSTRUMENT

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ZIMMER BIOMET, INC. COMPRHNSVE HYBRID GLEN ST SHNK DRL 15/64 EXTREMITIES, INSTRUMENT Back to Search Results
Catalog Number 406182
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 02/17/2020
Event Type  Malfunction  
Manufacturer Narrative

Cm(b)(4). Foreign: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up report will be submitted.

 
Event Description

It was reported that the distal part of the drill bit is broken. It broke while drilling. No piece fall into the patient body. All piece were found. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NameCOMPRHNSVE HYBRID GLEN ST SHNK DRL 15/64
Type of DeviceEXTREMITIES, INSTRUMENT
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 Key9828637
MDR Text Key188257304
Report Number0001825034-2020-01098
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number406182
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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