MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JACOBS CHUCK KEY; INSTRUMENT

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device history records were reviewed for lot 63273038 with no deviations or anomalies identified that would have contributed to the reported event.Receiving and inspections reports were reviewed for lot 80658412 which revealed all devices that were accepted, completed, and sent to inventory met specifications.The chuck key was returned for review.Visual inspection confirmed a rust spot on the t handle portion of the chuck key.This device is used for treatment.An initial product history search conducted 05/oct /2016 revealed no additional complaints against the related part and lot combination.This confirmed complaint out of box and risk assessment are being investigated.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

The customer found that rust was generated on the t-wrench surface.

• Brand Name: JACOBS CHUCK KEY
• Type of Device: INSTRUMENT
• 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: 7111988
• MDR Text Key: 95744705
• Report Number: 0001825034-2017-11115
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 00099905300
• Device Lot Number: 63273038
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1