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	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery, the swivelock anchors have either broken off or the thread has turned through, despite using a drill and tap.The broken pieces have 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 cmackenbach 03-jun-2025 further information was received that the first time, the swivelock broke off (at the bottom of the tip) from the ar-1593 set.The second time with the same patient, the swivelock was stripped.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error due to improper bone preparation, misaligned insertion, and/or prying/levering 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: 22282907
• Report Number: 1220246-2025-02515
• Device Sequence Number: 8876075
• Product Code: MAI
• UDI-Device Identifier: 00888867258686
• UDI-Public: (01)00888867258686(11)240409(17)260331(10)15232088
• 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): 11/13/2025

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: 03/31/2026
• Device Model Number: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• Device Catalogue Number: AR-1593
• Device Lot Number: 15232088
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown