MAUDE Adverse Event Report: ARTHREX, INC. SECONDARY FIXATION KIT, ACL/PCL REPAIR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SECONDARY FIXATION KIT, ACL/PCL REPAIR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 an acl suture surgery the anchor broke at the distal fixation.The broken off piece has been retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update dw 05-mar-2025: further information was provided that two additional sets have failed during the same surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified that the eyelet of the swivelock of the implant system, secondary fixation with 4.75 mm biocomposite swivelock®, acl/pcl repair had warped at the base.Also, the anchor noted had a surface damaged between the threads.-functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.Per dfu-0087-eo warnings - 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22158374
• Report Number: 1220246-2025-02399
• Device Sequence Number: 8678761
• Product Code: MAI
• UDI-Device Identifier: 00888867258686
• UDI-Public: (01)00888867258686(11)240220(17)260131(10)15210128
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151342
• 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,Followup
• Report Date (Section B): 07/29/2025

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 Expiration Date: 01/31/2026
• Device Model Number: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• Device Catalogue Number: AR-1593
• Device Lot Number: 15210128
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown