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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEXDRILL BIT 3.2X30 HIP INSTRUMENT

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ZIMMER BIOMET, INC. MODULAR FLEXDRILL BIT 3.2X30 HIP INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source (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 that during a hip procedure, the drill bit broke upon contact. Another drill was used to complete the surgery. No known adverse event was reported. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameMODULAR FLEXDRILL BIT 3.2X30
Type of DeviceHIP 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 Key8964288
MDR Text Key156720527
Report Number0001822565-2019-03819
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00879000703
Device LOT Number62848576
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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