MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED KNEE FIBERTAK, W/ NEEDLES; NON-DEGRADABLE FIXATION FASTENER

Model Number	DBL LOADED KNEE FIBERTAK, W/ NEEDLES
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/19/2024, it was reported by a sales representative via phone that (2) ar-3730sp double loaded knee fibertak anchor would not seat properly during insertion and were unable to capture.The case was completed using another ar-3730sp double-loaded knee fiber tap anchor from the same lot with no issues.There was a few minute delay in removing the anchors that would not seat.Nothing broke inside the patient, and no adverse effects on the patient.This was discovered during an mcl reconstruction procedure on (b)(6) 2024, with no reported patient harm.
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.
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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, improper bone preparation, and/or surgical technique.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• 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: 18836652
• Report Number: 1220246-2024-01296
• Device Sequence Number: 7499443
• Product Code: MBI
• UDI-Device Identifier: 00888867431645
• UDI-Public: 00888867431645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K231330
• 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): 06/04/2025

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: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• Device Catalogue Number: AR-3730SP
• Device Lot Number: 15138704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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