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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
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.Review of this complaint confirmed the event summary code selection.A product history review was performed as required.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.As no further investigation was able to be performed no change in harm was identified.Complaint trending for this event will be performed per (b)(4).
Event or Problem Description
On 09/16/2022, it was reported by a sales representative via sems that a ar-8927dsc disposables kits blue tap handle came loose while tapping a hole from the 4.5 corkscrew kit.Tap had to be removed with pliers since handle was spinning and no longer functional.This occurred during a distal biceps procedure on (b)(6) 2022.There was no patient effect reported.

• 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: 19369771
• Report Number: 1220246-2024-03632
• Device Sequence Number: 12693847
• Product Code: MDM
• UDI-Device Identifier: 00888867131538
• UDI-Public: 00888867131538
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 05/31/2026
• Device Model Number: 4.5X14MM CORKSCREW FT, DISPS
• Device Catalogue Number: AR-8927DSC
• Device Lot Number: 13622011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown