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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/29/2024, it was reported by a sales representative via phone that an ar-3610pk-3 fibertak, percutaneous insertion kit, and an ar-3636 knotless 1.8 fibertak soft anchor had breakage during use.When the ar-3610pk-3 fibertak drill bit was 2cm in, the end broke off in the tunnel and could not be retrieved.An x-ray was taken, and they could not find the broken piece in the patient.It was stated that it was contained in the tunnel, not the patient.While implanting the ar-3636 knotless 1.8 fibertak soft anchor, the surgeon had a hard time with implantation, and when removing the inserter for the anchor where it was held, it broke off.The case was completed using four more anchors of the ar-3636 from the same lot with no issues.The case was delayed a few minutes, and no reported additional anesthesia was administered.This was discovered during a shoulder labral repair procedure on (b)(6) 2024.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The device was not received for evaluation, and no evidence of the failure was received.

• 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: 18730793
• Report Number: 1220246-2024-01024
• Device Sequence Number: 12576601
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: 00888867358225
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 15182357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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