MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES STRAIGHT KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number FIBERTAK DISPOSABLES STRAIGHT KIT

Device Problem Device Damaged by Another Device (2915)

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

Event Date 05/25/2021

Event Type  malfunction  

Event Description

It was reported that the drill bit seized in the guide during use in an mpfl case.They used another ar-3638ds to complete the case.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-3638ds drill guide was received for investigation.Visual inspection identified that a drill bit was seized within the guide and attempts to separate the two devices were unsuccessful.A slight bend in the guide shaft was noted.The observed condition is most likely the result of prying/leveraging the bit within the guide, resulting in the two devices binding.

• Brand Name: FIBERTAK DISPOSABLES STRAIGHT KIT
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19173837
• MDR Text Key: 340975620
• Report Number: 1220246-2024-02318
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: 00888867287440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 13129088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1