MAUDE Adverse Event Report: BIOMET MICROFIXATION WIRE CUTTING PLIER D-A 22CM TC; PLIERS, SURGICAL

Catalog Number 51-0960

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

It was reported that during a procedure, the plate cutter fractured while cutting through a plate.No patient consequences were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 70-2001, lot# unknown; item# 73-2623, lot# unknown; item# 73-1952, lot# unknown; item# 73-2416, lot# unknown; item# 73-2418, lot# unknown; item# 73-2420, lot# unknown; and item# 73-1194, lot# unknown.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.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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned cutters.The cutters show signs of multiple uses including heavy marking/ scratching on the cutter surfaces.One of the two tips of the cutters has fractured.Medical records were not provided.Dhr review was not performed as product has approximate field age of 10 years, with an unknown number of uses.The device shows signs of repeated use.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: lot# - lot number is being updated to supplier lot number of e12.D4: udi - udi is being updated to ni as supplier's manufacturing records are unavailable for review.If any further information 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

No further event information available at the time of this report.

• Brand Name: WIRE CUTTING PLIER D-A 22CM TC
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15958731
• MDR Text Key: 305348085
• Report Number: 0001032347-2022-00362
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-0960
• Device Lot Number: E12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Age: 48 YR
• Patient Sex: Male