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	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/15/2022 it was reported by a sales representative via (b)(4) that an ar-8927dsc fell apart during a quad tendon repair procedure.Upon tapping the patella after drilling for the biocomposite 4.5 corkscrew, the blue handle attached to the metal tap began to spin around the actual tap.This made the device hard to advance forward and backward.The blue handle was pulled off the metal tap - as its adherence to each other was no longer - and attached a t-handle chuck to remove the tap from the bone.They kept the t-handle chuck on and used it for the other corkscrew as well.The case was completed successfully with no patient affect.
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.Visual inspection was unremarkable.Device was returned without the metal tap mentioned in the complaint.Complaint was not confirmed.

• 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: 19313007
• Report Number: 1220246-2024-03266
• Device Sequence Number: 6911223
• Product Code: MDM
• UDI-Device Identifier: 00888867131538
• UDI-Public: 00888867131538
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Model Number: 4.5X14MM CORKSCREW FT, DISPS
• Device Catalogue Number: AR-8927DSC
• Device Lot Number: 14935327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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