MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN GUIDE WIRE GRIPPER; PASSER, WIRE

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product-guide wire gripper catalog#:00249001200 lot#: 63017696.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001822565-2018-03164.

Event Description

It was reported that during an antegrade femoral nailing procedure, two (2) wire grippers failed to grip the 3.0 wire.There were no adverse events that occurred due to this malfunction.The surgery was completed successfully with another instrument.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event is confirmed as the 3.0mm hole exhibits wear and couldn't grip the cable properly.Visual inspection noted scratch marks on the impaction surface.The 3.0 mm hole exhibits wear indicative of use.The wear on the holes leads to insufficient gripping of guide wires.Dimensions taken are within spec as per the prints.During a functional check of mating components the 3.0 mm hole failed to securely grip the guide wire and the 2.4 mm hole securely gripped the guide wire.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause is determined to be normal wear during the instrument¿s field life.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZNN GUIDE WIRE GRIPPER
• Type of Device: PASSER, WIRE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7598271
• MDR Text Key: 111445287
• Report Number: 0001822565-2018-03165
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

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 Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 61877090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 04/18/2019
• Supplement Dates FDA Received: 08/08/2018; 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1