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

Model Number	DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Device not returning.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging during use.
Event or Problem Description
On 10/28/2022, it was reported by a sales representative via email that an ar-3638dhc fibertak curved drill guide was extremely tight and an ar-3636h self bunching 1.8 knotless hip fibertak would not cinch down all the way.This was discovered during a procedure on (b)(6) 2022.Additional information requested.

• Brand Name: DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
• 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: 19488409
• Report Number: 1220246-2024-05321
• Device Sequence Number: 7164967
• Product Code: LXH
• UDI-Device Identifier: 00888867295544
• UDI-Public: 00888867295544
• 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
• Report Date (Section B): 06/07/2024

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 KIT, CURVED, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638DHC
• Device Lot Number: 14796034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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