MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR EPAK DIST VLR PT STD R; TRAUMA IMPLANTS

Catalog Number 811812050

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Product received to zimmer biomet for investigation.Based on these inspection findings, it was determined that the root cause is associated with the radel material that is used in the plastic components in the kit.There is chlorine releasing from the radel material in parts per million, during gamma sterilization, that results in oxidation of the drill bits when exposed to extreme environmental conditions such as those experienced during transport.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 rusts were found on scale part of the 2.2mm drill bit and soft tissue guide at orif operation so another drill bit and guide were used to complete the procedure.No adverse event occurred.

• Brand Name: DVR EPAK DIST VLR PT STD R
• Type of Device: TRAUMA IMPLANTS
• 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: 6965591
• MDR Text Key: 89952861
• Report Number: 0001825034-2017-09442
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 811812050
• Device Lot Number: 213998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• 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