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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW DRILL 3.2 MM DIAMETER INSTRUMENT, SURGICAL

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ZIMMER BIOMET, INC. BONE SCREW DRILL 3.2 MM DIAMETER INSTRUMENT, SURGICAL Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Report source: event occurred in (b)(6).

 
Event Description

It was reported that during an initial tka, the surgeon was drilling through the cutting guide and the drill fractured inside of the patient's bone. The surgeon did notice this until the fragment was seen on x-ray postoperatively, and decided not to remain it. Attempts have been made and no further information has been provided.

 
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Brand NameBONE SCREW DRILL 3.2 MM DIAMETER
Type of DeviceINSTRUMENT, SURGICAL
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 Key9653531
Report Number0001822565-2020-00416
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00512008500
Device LOT Number55427000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/03/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/05/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/31/2020 Patient Sequence Number: 1
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