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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the tip of the blade snapped during surgery while cutting a wire.The fractured tip did not fall into the patient's mouth.No adverse events have been reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The smith wire cutter straight 16cm tc (part# 51-0928, lot# 102908j08) was visually evaluated.The cutters showed signs of normal use with scratches around the cutting blades.One of the two blades was also clearly fractured at the point where the screw locks the two halves together.The non-conformance report was reviewed, there is no non-conformance listed on the report for this part and lot.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to excessive force applied during use, beyond what the instrument is designed to encounter.The instructions for use (ifu) for this product states in the section titled 'warnings and precautions': avoid undue stress or strain when handling or cleaning instruments.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

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

• Brand Name: SMITH WIRE CUTTER STRAIGHT, POWER CUT
• Type of Device: WIRE CUTTER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7939713
• MDR Text Key: 123505703
• Report Number: 0001032347-2018-00677
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

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: 51-0928
• Device Lot Number: 102908J08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 11/05/2018; 01/03/2019
• Supplement Dates FDA Received: 12/03/2018; 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1