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	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion, prying/leveraging the device during insertion.
Event or Problem Description
On 12/02/2021, it was reported by a facility representative via sems that an ar-8927dsc 4.5x14mm corkscrew ft, disposables kit got damaged.The drill guide fused into the drill and damaged the rest of the products in the kit.The plastic melted.Another kit with a different lot number was used and it worked fine.This was discovered during use with no impact to the patient.

• 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: 19330221
• Report Number: 1220246-2024-03384
• Device Sequence Number: 20568480
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 11/30/2024
• Device Model Number: 4.5X14MM CORKSCREW FT, DISPS
• Device Catalogue Number: AR-8927DSC
• Device Lot Number: 10487094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown