• 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. UNKNOWN TARGETING JIG TRAUMA, INSTRUMENT

  • 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. UNKNOWN TARGETING JIG TRAUMA, INSTRUMENT Back to Search Results
Catalog Number UNKNOWN
Device Problems Fracture (1260); Failure to Align (2522)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) report source: (b)(6). Customer has indicated that 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 report will be submitted. Product not returned.
 
Event Description
It was reported that the implant was incorrectly positioned in the femur. The alignment was not verified prior to attempting to drill the screw holes. The drill became jammed in the implant and fractured. A guide wire was placed in the second screw hole on the proximal end of the nail and it also fractured. The surgeon successfully placed a screw in the third screw hole. The guide wire and drill fragments were left in situ. Attempts have been made and additional information on the reported event is unavailable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN TARGETING JIG
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 Key9929533
MDR Text Key186774612
Report Number0001822565-2020-01259
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/06/2020 Patient Sequence Number: 1
-
-