MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS, ARTHREX BROSTROM REPAIR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMP SYS, ARTHREX BROSTROM REPAIR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
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 arthroscopic repair of the lateral ligament according to brostrom (arthrobrostrom technique) the sutures disengange from both anchors of the kit.The surgery was finished successfully with a new device with another part number (ar-1902sf).It was necessary to change the surgical technique from arthroscopic to open surgery.A second operation was not necessary.

• Brand Name: IMP SYS, ARTHREX BROSTROM 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: 23742350
• Report Number: 1220246-2025-05460
• Device Sequence Number: 10208821
• Product Code: MAI
• UDI-Device Identifier: 00888867051263
• UDI-Public: (01)00888867051263(11)241007(17)280831(10)15327975
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K082810
• 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): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMP SYS, ARTHREX BROSTROM REPAIR
• Device Catalogue Number: AR-8936BC-CP
• Device Lot Number: 15327975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown