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	Foreign Body In Patient (2687)
Date of Event	05/06/2026
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 the anterior cruciate ligament surgery, the anchor broke off during insertion.A fragment of the broken anchor remained inside the patient's body.There was no harm for patient, operator or third party reported.No further information was received.Update 18-may-2026 - further information was received: it was reported that during the refixation of the anterior cruciate ligament, the biocomposite swivelock anchor broke off during insertion.A fragment of the broken anchor remained inside the patient's body.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device (ar-1588tb).It was not necessary to switch the surgical technique or do a second surgery.

• 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: 25285769
• Report Number: 1220246-2026-03000
• Device Sequence Number: 18663524
• Product Code: MAI
• UDI-Device Identifier: 00888867258686
• UDI-Public: (01)00888867258686(11)250723(17)270630(10)15471237
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/26/2026

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: SECONDARY FIXATION KIT, ACL/PCL REPAIR
• Device Catalogue Number: AR-1593
• Device Lot Number: 15471237
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown