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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER INSTUMENTATION, HIP

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ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER INSTUMENTATION, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the instrument became broken during drilling a screw hole during initial procedure. Attempts were made to obtain additional information; however, none was available.

 
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Brand NameFLEXIBLE SILICONE DRILL DRIVER
Type of DeviceINSTUMENTATION, 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 Key8947250
MDR Text Key160517126
Report Number0001825034-2019-03855
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110010733
Device LOT Number168731
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/20/2017
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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