MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-TENOD SCRW W/DISP DRV 4.0X10MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMP-TENOD SCRW W/DISP DRV 4.0X10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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
On (b)(6) 2025, it was reported by a sales representative via email that an ar-1540cds biocomposite-tenodesis screw 4 mm x 10 mm was inserted, but then the threads unraveled and broke.The broken pieces were retrieved from the patient, and the case was completed successfully.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Event or Problem Description
Additional information was received on 3/5/2025: this was discovered during an anatomic front and back wrist procedure.The case was completed using a 3.5 mm swivelock.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: BIO-COMP-TENOD SCRW W/DISP DRV 4.0X10MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 21594244
• Report Number: 1220246-2025-00917
• Device Sequence Number: 12881520
• Product Code: HWC
• UDI-Device Identifier: 00888867237230
• UDI-Public: (01)00888867237230(11)240620(17)260531(10)15276256
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 05/31/2026
• Device Model Number: BIO-COMP-TENOD SCRW W/DISP DRV 4.0X10MM
• Device Catalogue Number: AR-1540CDS
• Device Lot Number: 15276256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided; 09/04/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/20/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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