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

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products- cephalomedullary targeting guide standard, cat#: 00249000300 lot#: 63180825, impaction head, cat#: 00249003200 lot#: 61315915.Report source, foreign ¿ events occurred in (b)(6).Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a im nailing procedure, the guide wire would no longer grip.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Reported event is considered confirmed as visual examination showed the device had wear on the holes which leads to insufficient gripping of the guide wires.Dhr was reviewed and no discrepancies relevant to the reported event were found.This device has potentially been in the field for 8 years, therefore the root cause can be determined as 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 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: 7742660
• MDR Text Key: 115906629
• Report Number: 0001822565-2018-03977
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

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: 61571814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1