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

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As returned, the gripper does not properly grip a.1185 inch gage pin in the 3.0mm hole.The gripper would properly hold a.0945" pin in the 2.4mm hole and a.1185 inch gage pin in the 3.0mm hole.The gripper does not properly grip a.1185 inch gage pin in the 3.0mm hole with only the threaded rod being used to tighten it.Visual inspection concluded there are dents on the top and bottom surfaces of the gripper indicating previous use.Abrasion was also visible on the 3.0mm holes in the handle and pivot plate.Damage was also noted to the teeth.Manufacturing records for the lot were reviewed and do not indicate any manufacturing anomalies.The guide wire grippers were dimensionally analyzed and found to be within specification where measured.The gripper has a potential field age of approximately 1.5 years with an unknown number of uses.The device was used for treatment.The damage on the locking teeth might have contributed to the gripping condition.Due to the damage on the teeth, the gripper was not able to lock when fully stretched.Teeth damage might be due to wear and tear or excessive force applied on locking nut; however this cannot be confirmed.Elongation of the holes is probably wear due to normal use.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 the guide wire gripper allows wire to slip through it, and is not gripping properly.

• Brand Name: ZNN 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: 5650881
• MDR Text Key: 45095094
• Report Number: 1822565-2016-01028
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• 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: 61962249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2012
• 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