MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM PERC INSERT KIT FOR FIBERTAK; MANUAL INSTR, GENERAL SURGICAL

Model Number	1.8MM PERC INSERT KIT FOR FIBERTAK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/05/2024, it was reported by a sales representative via sems- (b)(4) that an ar-3610pk-3 percutaneous insertion kit for knotless fibertak anchor had the drill spot-welded with the guide when used.This was discovered during a procedure, with no reported patient harm.Additional information was received on 08/08/2024: this was discovered during a shoulder scope, labral repair procedure on (b)(6) 2024.The case was completed by using a straight guide fibertak disposable kit instead of the faulty 1.8 fibertak percutaneous kit.There was no case delay reported and no adverse effects on the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: 1.8MM PERC INSERT KIT FOR FIBERTAK
• 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: 20086197
• Report Number: 1220246-2024-07286
• Device Sequence Number: 12678489
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: 00888867358225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/02/2025

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: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Device Catalogue Number: AR-3610PK-3
• Device Lot Number: 15229830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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