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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STN PIN 2.0MM STYLE #6 STERILE TRAUMA DISPOSABLES

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ZIMMER BIOMET, INC. STN PIN 2.0MM STYLE #6 STERILE TRAUMA DISPOSABLES Back to Search Results
Model Number N/A
Device Problems Tear, Rip or Hole in Device Packaging; Device Disinfection Or Sterilization Issue
Event Date 01/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Product was returned to zimmer biomet. "upon evaluation the complaint was confirmed as the steinmann pin punctured through the sterile packaging and the cardboard tip protector. The sterile packaging was most likely punctured by the pin. A change has since been implemented and the pin is now packaged with polyurethane tip protectors to prevent this event from occurring. This product is deemed to be conforming when it left zimmer biomet control. " review of complaint history found no additional related issues for this item. Review of device history records found these units were released to distribution with no deviations or anomalies. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. This report is being submitted late as it has been identified in remediation.

 
Event Description

It was reported that during a chevron bunionectomy procedure on (b)(6) when the steinmann pin was opened, the pin was found sticking through the sterile packaging. Another steinmann pin was used to complete the procedure.

 
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Brand NameSTN PIN 2.0MM STYLE #6 STERILE
Type of DeviceTRAUMA DISPOSABLES
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 Key6941922
Report Number0001825034-2017-08524
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL NumberN/A
Device Catalogue Number450093
Device LOT Number809240
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/25/2009
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

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