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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MMX40MM RNGLC+ ACET DRL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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ZIMMER BIOMET, INC. 3.2MMX40MM RNGLC+ ACET DRL BIT ORTHOPEDIC MANUAL SURGICAL 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 07/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: 31-323230 3. 2mmx30mm bit 023880. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03454.

 
Event Description

It was reported that the drill bits broke during procedure. Attempts were made to obtain additional information; however, none was available.

 
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Brand Name3.2MMX40MM RNGLC+ ACET DRL BIT
Type of DeviceORTHOPEDIC MANUAL SURGICAL 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 Key8869128
MDR Text Key194968994
Report Number0001825034-2019-03456
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 09/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number31-323240
Device LOT Number707070
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2015
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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