MAUDE Adverse Event Report: BIOMET MICROFIXATION SMITH WIRE CUTTER, STRAIGHT, POWER CUT 16CM; CUTTER, WIRE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The product has been returned to zimmer biomet for evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tip fractured on a pair of wire cutters.The malfunction was discovered during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was performed on the product and a small chip could be seen in one of the cutter blades.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to the tip fracturing for 51-0928 lot 071317g17.For this part (51-0928) and the previous one year (from the notification date) regarding the tip fracturing, (b)(4).The most likely underlying cause is excessive force being applied to the tip that was more than the product is designed for.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: SMITH WIRE CUTTER, STRAIGHT, POWER CUT 16CM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9823341
• MDR Text Key: 191159459
• Report Number: 0001032347-2020-00160
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 00841036048105
• UDI-Public: 00841036048105
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• 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: 51-0928
• Device Lot Number: 071317G17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1