MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR EPAK LOCK PLT L; FIXATION, APPLIANCE

Model Number N/A

Device Problems Corroded (1131); Device Contamination with Body Fluid (2317)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The instrument tray presented with a radius plate with what appeared to be tissue residues on most surfaces.The residue transferred to the tray was removed and tested positive for blood.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.Zimmer biomet complaint number: (b)(4).

Event Description

It was reported that after the sterile packaging of an epak dvr plate was opened, the nurse noticed that there were some dark brown dust on the plate and instrument of which got on the nurse's glove.A dvr anatomic plate was used in the procedure.No further information has been provided.Additional information received indicated that blood was found on the plate.As per biomet (b)(4), the product was not implanted but it may have come into some contact with blood when the package was opened.No further information is available.

• Brand Name: DVR EPAK LOCK PLT L
• 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: 6930859
• MDR Text Key: 89189556
• Report Number: 0001825034-2017-08234
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 811822050
• Device Lot Number: 214067
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• 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