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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0MM CANNULATED DRILL BIT, DRILL

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ZIMMER BIOMET, INC. 5.0MM CANNULATED DRILL BIT, DRILL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source: (b)(6). 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.

 
Event Description

It was reported that during surgery, the drill bit fractured inside the patient. The fractured piece remains inside the patient. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand Name5.0MM CANNULATED DRILL
Type of DeviceBIT, DRILL
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 Key8965906
MDR Text Key156630739
Report Number0001825034-2019-03971
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number14629
Device LOT NumberZB170603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/05/2019 Patient Sequence Number: 1
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