MAUDE Adverse Event Report: ZIMMER INC VERSA-FX FEMORAL LINKED LAG SCREW INSERTER; HWR

Catalog Number 00119301200

Device Problems Fracture (1260); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Two lag screw inserters were returned and confirmed to be fractured.Visual exam noted both lag screw inserters to be fractured at the distal end that is to be inserted into bone.Device history record review of lag screw inserters found conformed.The first inserter has a potential field age of roughly 3 years.The second inserter has a potential field age of over 6.5 years.Print specifications were met on all devices where measured.The device is used for treatment.Previous investigation through scanning electron microscopy (sem) has found the failure mode to likely be caused by torque overload.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 a versa fx trauma surgery, a lag screw inserter and inserter rod broke while implanting the lag screw.A second inserter was then flash sterilized from another set for use, and it broke as well.The surgeon then switched from a 3-hole keyed implant to a 4-hole keyless implant.

• Brand Name: VERSA-FX FEMORAL LINKED LAG SCREW INSERTER
• 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: 5570931
• MDR Text Key: 42439274
• Report Number: 1822565-2016-01162
• 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: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00119301200
• Device Lot Number: 61793923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2011
• 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
• Patient Age: 17 YR