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

Catalog Number 00119301200

Device Problems Fracture (1260); Use of Device Problem (1670)

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

Event Date 10/22/2014

Event Type  malfunction  

Manufacturer Narrative

The device met print specifications where measured.The instrument returned was confirmed to be broken/fractured.As returned, the lag screw inserter was fractured near the lag screw connection end.There are some minor scuffs on the inserter especially in the connection regions.The device was used for treatment.The scuffs indicate previous effective use of the inserter over its potential field age of approximately six years.Excessive torque loads may damage the screw inserter if applied in an off-axis manner or if the inserter is used without being fully seated on the lag screw.If the patient had hard bone, it may have also contributed to the fracture of the device.The usage history of the inserter is not known.A definitive root cause cannot be determined.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

While physician was placing the versafix lag screw implant, the tip of the inserter broke off inside the patient.The inserter and the broken piece were removed from the surgical site.

• Brand Name: VERSA-FX LAG SCREW INSERTER
• Type of Device: HWR
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5567826
• MDR Text Key: 42351325
• Report Number: 1822565-2016-01069
• 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: 10/23/2014

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: 00119301200
• Device Lot Number: 61112584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2008
• 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