• 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. SCREW T15 LP CORT 3.5X26MM NS SCREW, FIXATION

  • 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. SCREW T15 LP CORT 3.5X26MM NS SCREW, FIXATION Back to Search Results
Catalog Number 110017726
Device Problem Material Frayed (1262)
Patient Problem Injury (2348)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Foreign: (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 a screw fractured during insertion. A small bit of metal debris cut surgeons hands. Had to wash wound with antiseptic and re-glove.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSCREW T15 LP CORT 3.5X26MM NS
Type of DeviceSCREW, FIXATION
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 Key11139418
MDR Text Key225750388
Report Number0001825034-2021-00044
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK083843
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 06/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number110017726
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 Received06/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/08/2021 Patient Sequence Number: 1
-
-