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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. T6 HEXALOBULAR DRIVE AO 2.0MM PROSTHESIS SHOULDER

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ZIMMER BIOMET, INC. T6 HEXALOBULAR DRIVE AO 2.0MM PROSTHESIS SHOULDER Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
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 during an initial surgery, the tip of the t-6 driver broke off, it was not while locking the screw into the plate, there was zero abnormal resistance on the screw, and the tip broke off. Nothing was available to finish the case.

 
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Brand NameT6 HEXALOBULAR DRIVE AO 2.0MM
Type of DevicePROSTHESIS SHOULDER
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 Key9874387
MDR Text Key186120919
Report Number0001825034-2020-01262
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberIFI-491436
Device LOT Number4562991
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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