MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK, DOUBLOAD FW BL/W, BLK/W; NON-DEGRADABLE FIXATION FASTENER

Model Number	FIBERTAK, DOUBLOAD FW BL/W, BLK/W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an rm suture while inserting the anchor, the anchor backed out of the bone.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with a different part number.It was not necessary to switch the surgical technique or do a second surgery.30-jul-2021 dw update: further information were provided that no additional hole was needed.The surgeon used the same hole with the new device.
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.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• Brand Name: FIBERTAK, DOUBLOAD FW BL/W, BLK/W
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19267157
• Report Number: 1220246-2024-02936
• Device Sequence Number: 15310906
• Product Code: MBI
• UDI-Device Identifier: 00888867276871
• UDI-Public: 00888867276871
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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 Expiration Date: 10/31/2025
• Device Model Number: FIBERTAK, DOUBLOAD FW BL/W, BLK/W
• Device Catalogue Number: AR-3630-1
• Device Lot Number: 12187448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown