MAUDE Adverse Event Report: ARTHREX, INC. DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via e-mail that an ar-3638dhc disposbales kit, for knotless hip fibertak® suture anchor, broke.This occurred during a procedure on (b)(6) 2024 when the device broke, the piece was embedded in bone and they had to dig to get it out adding about 30 minutes to the case.No additional information was provided, and additional information has been asked.Additional information received on 4/30/2024: this was discovered during a hip labral repair procedure.The drill bit was used in the patient, and it broke.Unfortunately, it was not noticed until the x-ray was taken for the cam resection.At the time of the device breaking, there was still more to do in the procedure; the sales representative was unsure how much anesthesia was administered.Initially, part number ar-3638dhc disposables kit was reported as the faulty device; however, the sales representative has reported that the correct part number is ar-3638dhc-2 disposables kit.The procedure was completed using products from another manufacturer.
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 distal tip is broken off.Since the device was not returned for evaluation, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion, prying, and leveraging the device during use.

• Brand Name: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19369841
• Report Number: 1220246-2024-03635
• Device Sequence Number: 7619588
• Product Code: LXH
• UDI-Device Identifier: 00888867430044
• UDI-Public: 00888867430044
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/21/2025

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: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• Device Catalogue Number: AR-3638DHC-2
• Device Lot Number: 15153261
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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