MAUDE Adverse Event Report: ARTHREX, INC. 4.5X14MM CORKSCREW FT, DISPS; MANUAL INSTR, GENERAL SURGICAL

Model Number	4.5X14MM CORKSCREW FT, DISPS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the drill guide ar-8927dsc, broke while drilling.Drill guide is stuck in drill.The case was completed by using another drill without further issue.
Additional 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, the drill bit is stuck in the guide.The guide was also found to have broken off from the handle.Relevant dimensional features could not be measured due to the damage and condition.The most likely cause of the event is prying/leveraging the drill bit and/or user-applied mechanical forces.

• Brand Name: 4.5X14MM CORKSCREW FT, DISPS
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19547156
• Report Number: 1220246-2024-05866
• Device Sequence Number: 6806119
• Product Code: MDM
• UDI-Device Identifier: 00888867131538
• UDI-Public: 00888867131538
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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 Expiration Date: 07/31/2025
• Device Model Number: 4.5X14MM CORKSCREW FT, DISPS
• Device Catalogue Number: AR-8927DSC
• Device Lot Number: 11536705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown