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

Catalog Number 00249001200

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/15/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4.) information was received from a foreign source who is not required to complete form 3500a.Evaluation of the returned instrument noted scratches on the top and bottom indicating use; thread damage was noted where the product clamps into place, with some discoloration was found on the device sides.The 3.0mm and 2.4mm holes were not found to be worn or mis-shapen during visual exam.Device history record reviews found lot conformed at the time of manufacture as part of this investigation the lot was re-reviewed and found conforming.The wire grippers were also evaluated by dimensional analysis, hardness test and functional tests.Device met print specifications and was noted to be roughly 1.5 years old.It is unknown how many times the device was used.The device is used for treatment.The root cause of the complaint is normal wear to the device over its 1.5 year lifetime.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 surgery, the guide wire gripper did not fasten over the 3.0 mm guide wire.

• Brand Name: ZIMMER ZNN GUIDE WIRE GRIPPER
• Type of Device: HWI
• 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: 5571348
• MDR Text Key: 42984465
• Report Number: 1822565-2016-01068
• 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: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 62235899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1