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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 2.7 MM DIAMETER BIT, DRILL

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ZIMMER BIOMET, INC. DRILL STANDARD 2.7 MM DIAMETER BIT, DRILL Back to Search Results
Model Number 2360-205-27
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/27/2020
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 the drill fractured during surgery and the broken piece was left in the patient's bone. The surgeon used another drill from the set to complete the surgery. There were no attempts to retrieve the broken pieces. No patient consequences were reported at the time of this report. No additional information is available at this time.

 
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Brand NameDRILL STANDARD 2.7 MM DIAMETER
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 Key9947938
MDR Text Key187388782
Report Number0001822565-2020-01343
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2360-205-27
Device Catalogue Number00236020527
Device LOT Number64124070
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 Received07/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/27/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/10/2020 Patient Sequence Number: 1
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