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	Foreign Body In Patient (2687)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/3/2024, it was reported by a sales representative via (b)(4) that an ar-3610pk-3 fibertak, percutaneous insertion kit had a drill break at the tip during use.The tip was not retrieved from the patient.The standard technique was being used in hard bone.The drill tip broke on the last anchor hole and was not needed for the rest of the case.The anchor deployed and firmly held in the hole.There was no delay to the case.
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 the complaint allegation is confirmed.Based on the images provided from the field, it is evident that the device had a puncture below the cutting tip.Consequently, arthrex was able to conclude the most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion, prying, and leveraging the device.

• 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: 19644882
• Report Number: 1220246-2024-06527
• Device Sequence Number: 6578734
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: 00888867358225
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 06/11/2025

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: 15207672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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