MAUDE Adverse Event Report: ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP; NON-DEGRADABLE FIXATN FASTENER

Model Number	HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during the hip arthroscopy with acetabular labrum repair, the implants of the ar-3602h-1 (case-(b)(4) to -5) failed to achieve adequate bone fixation and subsequently pulled out.Additionally, the blue suture of one ar-3636h-1 (case-(b)(4) became jammed, preventing the loop from being tightened.For another ar-3636h-1 (case-(b)(4), the suture was severed by the inserter.Furthermore, two implants of the ar-3636h-1 (case-(b)(4) and case-(b)(4) failed to achieve adequate fixation and pulled out.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with new devices from arthrex and stryker.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 25443936
• Report Number: 1220246-2026-03289
• Device Sequence Number: 15842032
• Product Code: MBI
• UDI-Device Identifier: 00888867295537
• UDI-Public: (01)00888867295537(11)221214(17)271130(10)15034202
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: HIP FIBERTAK SUTR ANCH, W/ 1.3MM SUTRTP
• Device Catalogue Number: AR-3602H-1
• Device Lot Number: 15034202
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown