MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER CABLE CUTTER; TRAUMA INSTRUMENT

Catalog Number 00392501100

Device Problem Bent (1059)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, not yet evaluated.

Event Description

It is reported that the surgeon noticed that the cable cutter was not cutting efficiently during use in surgery and the blades of the cutter were bent and/or damaged.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.As returned the jaw edges were found to be gouged.The hardness is within specification.Review of device history records indicated that the devices were manufactured to specifications with no deviations to the standard manufacturing processes.This device was used for treatment.The driver had a potential field age of approximately 1 year 2 months at the time of the reported incident with an unknown usage history.A complaint history review was conducted for the device and identified no additional complaints for the same lot.Per the package insert, ¿end life of device is normally determined by wear and damage due to use.¿ it also states that ¿if damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.¿ it is likely that device failed to cut due to wear and tear from multiple usages over the potential field life.The root cause of the event is determined to be wear and tear from use.

• Brand Name: ZIMMER CABLE CUTTER
• Type of Device: TRAUMA INSTRUMENT
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5974131
• MDR Text Key: 55808731
• Report Number: 0001822565-2016-03403
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00392501100
• Device Lot Number: 63119279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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