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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/18/2015

Event Type  malfunction  

Manufacturer Narrative

The flexible driver was returned and a visual inspection was performed which showed a damaged flex shaft.The device was used for treatment.Based on the manufacturing date, the reported device has a field life of approximately 7 years to date.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 while the surgeon was drilling a screw hole, the spring of the flex driver unraveled.

• 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: 5636853
• MDR Text Key: 44617526
• Report Number: 0001822565-2016-01457
• 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: 936600066
• Device Lot Number: 60878462
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2008
• 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