MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS HIP FIBERTAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
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)2023, it was reported by a patient via email that (3) arthrex 3.0mm knotless all suture anchors with #2 fiberwire sutures were implanted during a right hip fai procedure on (b)(6)2021.Then, on (b)(6)2022, the patient underwent another procedure for a right hip fai in which an arthrex 2.4mm peek pushlock anchors with #2 fiberwire sutures and (6) arthrex 1.8mm knotless all suture anchors with #2 fiberwire sutures was implanted.The patient is now experiencing an allergic reaction.No additional information has been reported.Additional information received on 5/5/2023: the procedure on (b)(6)2021 was a right hip arthroscopy, labral repair, femoroplasty, acetabuloplasty, capsulectomy, synovectomy, chondroplasty, iliopsoas bursectomy, injection, and aspiration.A total of four ar-3638h knotless hip fibertak were implanted.Shortly after the procedure, the patient experienced ongoing pain with no relief of discomfort, which led to seeking an opinion from an immunologist.An allergy patch test was conducted, and it confirmed positive for several metals and materials.The patient was not treated for a possible allergic reaction, as the material composition for the arthrex devices was unknown by the surgeon.On (b)(6)2022, the patient undergoes right hip arthroscopy, labral augmentation vs.Reconstruction, synovectomy, chondroplasty, capsulectomy, acetabuloplasty, and iliopsoas bursectomy.It is unknown by the patient if any of the four ar-3638h knotless hip fibertak implanted during the original procedure were explanted during the revision procedure.During the revision surgery, two ar-2924phs peek, mini hip pushlock, five ar-3636h self bunching 1.8 knotless hip fibertak, and an ar-3638h knotless hip fibertak were implanted.Even after the revision surgery, the patient is still experiencing pain, discomfort, and limited range of motion.Both procedures were performed by the same surgeon and at the same facility.
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 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 patient-specific event.

• Brand Name: KNOTLESS HIP FIBERTAK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17014526
• Report Number: 1220246-2023-06796
• Device Sequence Number: 17886398
• Product Code: MBI
• UDI-Device Identifier: 00888867295568
• UDI-Public: 00888867295568
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638H
• Device Lot Number: 10405612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown