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

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

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.

• Brand Name: STN PIN 2.0MM STYLE #6 STERILE
• Type of Device: TRAUMA 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 Key: 6941922
• MDR Text Key: 90296981
• Report Number: 0001825034-2017-08524
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 450093
• Device Lot Number: 809240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR