MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2025
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
On 3/7/2025, a facility representative reported via phone and email that an ar-4020c-08 fastthread biocomposite interference screw 8 x 20 mm broke postoperatively in a patient after a soccer injury, resulting in additional surgery on (b)(6) 2025.The patient had the first acl procedure on the right knee on (b)(6) 2024.Two ar-4020c-08 fastthread biocomposite interference screws were implanted successfully, and the patient had no issues afterward.Beginning of (b)(6) 2025, the patient obtained a subsequent injury during a soccer game.X-rays were not taken, but the doctor made a physical diagnosis.A right knee arthroscopy loose body excision was performed on (b)(6) 2025 for the removal of a posttraumatic osteochondral loose bone body along with one 2x2 mm dissolving implant fragment broken off one ar-4020c-08 fastthread biocomposite interference screw 8 x 20 mm.The other screw parts remained inside the patient.The additional surgery was completed successfully, and the patient was fine to date.
Additional Manufacturer Narrative
Additional information: d6a, d6b, g3, h3, h6.Complaint allegation is not confirmed.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.Per dfu-0111-eo c.Contraindications - 7.Conditions that tend to limit the patient¿s ability or willingness to restrict activities or follow directions during the healing period.E warnings - 6.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: Ø8X 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: 21663073
• Report Number: 1220246-2025-01095
• Device Sequence Number: 7713637
• Product Code: MAI
• UDI-Device Identifier: 00888867276963
• UDI-Public: (01)00888867276963(11)240805(17)280731(10)15297185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: Ø8X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-08
• Device Lot Number: 15297185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown