MAUDE Adverse Event Report: BIOMET MICROFIXATION SMITH WIRE CUTTER WITH NOTCH; CUTTER, WIRE

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.

Event Description

It was reported that the wire cutters have a fractured tip and the damage was noticed during a case.The procedure was completed with a back up instrument.No adverse events were reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was conducted on the cutter.The cutter shows signs of wear including scratching on the cutter surface.The cutter's cutting tip has a slight chip and as a result the cutters will no longer cut properly.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 instrument being chipped for 51-0929 lot 051319e19.The most likely underlying cause of the complaints is that excessive force was used, beyond what the instrument was designed to encounter.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.

Event Description

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

• Brand Name: SMITH WIRE CUTTER WITH NOTCH
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10159165
• MDR Text Key: 195294433
• Report Number: 0001032347-2020-00269
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 00841036048112
• UDI-Public: 00841036048112
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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: 51-0929
• Device Lot Number: 051319E19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1