MAUDE Adverse Event Report: ZIMMER, INC. ACETABULAR SYSTEM FLEXIBLE DRIVER; HWR

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Date 03/11/2015

Event Type  malfunction  

Manufacturer Narrative

Device was returned with complaint for an evaluation.A visual inspection of the returned flexible driver shows a deformed flex shaft.Device shows evidence of wear since lot number was worn and not legible for determination; therefore, a device history record review was not performed as the lot number was unknown.The device was used for treatment.The reported device has a field life of more than 15 years to date based on the markings on the device.This type of event may be related (but not limited) to: excessive force that may have been applied during usage, continued operation of the drill after it was stuck against hard material, rapid forward and reversal of direction of rotation when the device is stuck, excessive bending around corners, device wear due to usage with time, and low speed/high torque of operation.A definitive root cause for this event was not determined with the information provided.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that during surgery the flexible shaft instrument bent.

• Brand Name: ACETABULAR SYSTEM FLEXIBLE DRIVER
• Type of Device: HWR
• 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 46581-0708 ; 8006136131
• MDR Report Key: 5637017
• MDR Text Key: 44611670
• Report Number: 0001822565-2016-01483
• 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: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• 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: 36600066
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1