MAUDE Adverse Event Report: ZIMMER INC GUIDE WIRE GRIPPER; HXI

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device returned condition was noted as: visible dents on surfaces of the gripper indicating previous effective use; abrasion visible on 3.0mm holes of handle and pivot plate which were elongated; threads damaged; and handle showed signs of wear by noted dents and scuffs.Review of device history records review found no anomalies.Guide wire grippers were dimensionally analyzed and met print specification, including hardness testing.Due to damage on the teeth, the gripper was noted to be unable to lock at fully stretched condition.This device is used for treatment.The damage on the locking teeth may have contributed to the gripping condition.Probable cause of elongation of the hole feature is likely wear due to normal use and teeth damage might be due to wear and tear or excessive force applied on locking nut but this cannot be confirmed with available information.The gripper has a potential field age of approximately 1.5 years with an unknown number of uses.Device has reached the end of its useful life.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It is reported during surgery, the guide wire gripper no longer holds 3.0 mm guide wire.

• Brand Name: GUIDE WIRE GRIPPER
• Type of Device: HXI
• 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: 5571481
• MDR Text Key: 42991796
• Report Number: 1822565-2016-01212
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/15/2014

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00249001200
• Device Lot Number: 62006692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• 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