MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD QUICK-RELESE DRILL CHUCK; BIT, DRILL

Model Number N/A

Device Problem Residue After Decontamination (2325)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported event is confirmed.Visual examination of the returned device determined that it had scratches suggesting repeated use.This part was returned with the zimmer instruments which were returned due to black residue on them and some water marks are also observed on this biomet part.Device history record (dhr) was reviewed and no discrepancies were found.Sem micrographs and eds elemental analysis of the debris on the zimmer femoral provisional that were also returned with this device, found that there was rust like indication on the laser etched areas of the instruments.The residue showed high concentration of (o, mn and cl) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed cl, c, si, ca, and al.The root cause for the black residue on the returned instruments is attributed to a maintenance issue due to following reason.All the metallic instruments contained in the trays show water marks.Some of the chemical elements (ca, s, o) do not come from the instruments themselves, but could come from caso4 contained in hard water.The black residue is spread on each and all the metallic instruments, which is only possible through contact with air and water.The recommended cleaning steps were not followed based on the provided information.The hospital reported they had undergone maintenance one week prior to this occurrence.Review of the complaint history determined that no further action is required.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported during initial operating room setup, the nurse handling the instruments discovered black residue on her gloves.Subsequently, there was noticed to be black debris on some of the instruments.There were five sets examined and all five sets had the same black debris.No patient consequences were reported as a result of the malfunction with this instrument.

• Brand Name: VANGUARD QUICK-RELESE DRILL CHUCK
• Type of Device: BIT, DRILL
• 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: 7373204
• MDR Text Key: 103547346
• Report Number: 0001825034-2018-02224
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-486259
• Device Lot Number: ZB160501
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1