MAUDE Adverse Event Report: ZIMMER INC. ACETABULAR UNIVERSAL FIXED ANGLE DRIVER; HWR

Catalog Number 936600060

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 09/08/2014

Event Type  malfunction  

Manufacturer Narrative

The angled driver returned has a prong fractured off the collet.The device has a potential field age of over 6 years to date.The actual frequency of use is unknown.Manufacturing documentation was reviewed and found conforming to specifications at the time of manufacture.No additional complaints have been received against the manufacturing lot of the returned device.The device was used for treatment.It is unknown if excessive force was being used or if the device was being used to drill into hard bone.With the information provided, a definitive root cause cannot be determined, but it appears that the device has reached the end of its usable life, likely due to wear and tear from use.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

Tooth is broken so it will not hold the tap.

• Brand Name: ACETABULAR UNIVERSAL FIXED ANGLE DRIVER
• Type of Device: HWR
• Manufacturer (Section D): ZIMMER INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5566567
• MDR Text Key: 42270386
• Report Number: 1822565-2016-01022
• Device Sequence Number: 1
• Product Code: HWR
• 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
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 936600060
• Device Lot Number: 61013527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1