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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED DRILL CANNULATED SHORT 4.9 MM TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. CALIBRATED DRILL CANNULATED SHORT 4.9 MM TRAUMA, INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Foreign: event occurred in (b)(6). The product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded.

 
Event Description

It was reported that during surgery, when the surgeon was drilling with 4. 9mm drill over the guide pin, the tip of the drill fractured inside the patient bone. There was a delay of 15 mins as a result of this event. Attempts have been made and additional information on the reported event is unavailable at this time. No additional patient consequences were reported.

 
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Brand NameCALIBRATED DRILL CANNULATED SHORT 4.9 MM
Type of DeviceTRAUMA, 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 Key9732352
Report Number0001822565-2020-00581
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00249006450
Device LOT Number62270443
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 Received01/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 02/20/2020 Patient Sequence Number: 1
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