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

Catalog Number 00249001200

Device Problems Material Fragmentation (1261); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Dents and scratching are visible on the top and bottom striking surfaces of the gripper indicating previous effective use.Slight abrasion was observed around the guide wire holes on the device.Damage was also noted to the threads of the threaded rod.Damage was noted to the locking teeth.Previous review of manufacturing records indicated the device was conforming to specifications at the time of manufacture.The guide wire grippers were found to be within specification where measured.This device is used for patient treatment.The damage on the locking teeth may have contributed to the guide wire sliding through the holes, as exhibited during the functionality test.The probable cause for the elongation of guide wire 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; however this cannot be confirmed with available information.The gripper has a potential field age of approximately four years with an unknown number of uses.The device has reached the end of its useful life.Due to previous reports, a new design was released to increase the hardness of the strike plate and tighten tolerance of the guide wire hole.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported the guide wire gripper would not grip guide wire to pull on as instrument is intended.

• Brand Name: GUIDE WIRE GRIPPER
• Type of Device: HXI
• Manufacturer (Section D): ZIMMER INC.; p.o. box 708; warsaw IL 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw 46581-0708 ; 8006136131
• MDR Report Key: 5566581
• MDR Text Key: 42267468
• Report Number: 1822565-2016-01023
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/11/2014

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: 00249001200
• Device Lot Number: 61571812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2010
• 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