MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
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 a surgery the screw broke.Per complaint reporter there was no harm for patient, operator or third party.No further information received.

• Brand Name: Ø9X 20MM BC IF SCRW, VENTED
• 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: 25232236
• Report Number: 1220246-2026-02928
• Device Sequence Number: 10238002
• Product Code: MAI
• UDI-Device Identifier: 00888867276970
• UDI-Public: (01)00888867276970(11)241104(17)281031(10)15341899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Device Lot Number: 15341899
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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