MAUDE Adverse Event Report: ZIMMER, INC. SMALL DEPTH GAUGE; GAUGE, DEPTH

Catalog Number 00481000201

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the depth gauge did not have any of the laser etch marks on it to demark the depth.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Both the gauges were received for evaluation.If was found that one set of gauges have etched lines but were worn down due to multiple autoclave cycles and the other gauges have lines present.Both gauges are not new out of the package and show signs of wear.The device history records were reviewed for both gauges with no deviations or anomalies being identified.The gage had a potential field age of approximately 10 years and have been in use since (b)(6) 2006 with an unknown usage and handling history at the time of the reported event.This device is used for treatment.The complaint history review was conducted for the devices and found no additional complaints for the same lot.Root cause is general wear from repeated cleaning, sterilization, and usage cycles.

• Brand Name: SMALL DEPTH GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6019976
• MDR Text Key: 57052679
• Report Number: 0001822565-2016-03668
• Device Sequence Number: 1
• Product Code: HTJ
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00481000201
• Device Lot Number: 56475879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2006
• 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