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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
This follow-up report is being submitted to relay additional information.
Additional 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
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9823341
• Report Number: 0001032347-2020-00160
• Device Sequence Number: 2718046
• Product Code: HXZ
• UDI-Device Identifier: 00841036048105
• UDI-Public: 00841036048105
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1