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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UJOINT SCRW DRVR BIT 3.5 HEX PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UJOINT SCRW DRVR BIT 3.5 HEX PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). D11: (b)(6). 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 the patient underwent an initial total hip arthroplasty. During the procedure, the articulating screwdriver tip sheared off while removing the screw covers. They were able to retrieve all the metal. The apical hole plug stripped. The surgeon was unable to remove the stripped apical hole plug, and were unable to use the dual mobility poly as a result. They attempted to remove the plug with the flexible screwdriver, straight driver, additional articulating driver, and a screw removal tray. There was no patient harm or delay in surgery. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameUJOINT SCRW DRVR BIT 3.5 HEX
Type of DevicePROSTHESIS, 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 Key9841435
MDR Text Key188265669
Report Number0001825034-2020-01135
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 DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number31-424202
Device LOT NumberZB160301
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

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