• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 2.0 MM DIAMETER BIT, DRILL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. DRILL STANDARD 2.0 MM DIAMETER BIT, DRILL Back to Search Results
Catalog Number 00236017520
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 03/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source: foreign-(b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the drill bit was found broken before the surgery. There was no patient involvement or harm to the patient as a result of this malfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRILL STANDARD 2.0 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 Key9902710
MDR Text Key185713275
Report Number0001822565-2020-00938
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeJO
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00236017520
Device LOT Number63914587
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 Received08/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/08/2018
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

-
-