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

Model Number N/A

Device Problems Corroded (1131); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

Reported event was confirmed by review of photographs provided.Based on these inspection findings, it was determined that the root cause of the rust 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.Dhr was reviewed and no discrepancies were found.Review of the complaint history identified an issue that was already addressed in the past.Completion of the investigation relayed to biomet (b)(4).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.(b)(4).

Event Description

It was reported that something like rust was found on the drill bit surface at operation.Another drill bit was used to complete the procedure.No adverse event has been reported to date.

• Brand Name: DVR EPAK DIST VLR PT STD R
• Type of Device: FIXATION, APPLIANCE
• 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: 6937717
• MDR Text Key: 89045073
• Report Number: 0001825034-2017-08339
• 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: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 811812050
• Device Lot Number: 214006
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1