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	01/03/2025
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 a sidebands surgery the anchor broke, although made with the correct drill and tap according to the surgeon.All fragments were 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-1593 batch 15210128 was received for investigation.Visual inspection identified the tip and threads of the bio/anchor had warped and broken off.No damage was observed on the eyelet, handle, and/or sutures.Functional testing was performed by moving the inner molded shaft in and out of the inner molded shaft to look for resistance.No issues were found.The most likely cause of the reported failure is user error, specifically due to improper bone preparation, misalignment during insertion, and/or prying or leveraging 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: 21264669
• Report Number: 1220246-2025-00104
• Device Sequence Number: 9539111
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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