MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPRESSION SCREW 2.7 X 20MM; BONE FIXATION SCREW/PLATE

Model Number	BIO-COMPRESSION SCREW 2.7 X 20MM
Medical Device Problem Codes	Break (1069); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint locking (2672); Foreign Body In Patient (2687)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three months after a surgery with a bio compression screw the patient reported a locking knee.It was further reported that a screw fragment was found broken in the patients knee.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 a patient-specific event.

• Brand Name: BIO-COMPRESSION SCREW 2.7 X 20MM
• 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: 21901684
• Report Number: 1220246-2025-01705
• Device Sequence Number: 4059427
• Product Code: HWC
• UDI-Device Identifier: 00888867034709
• UDI-Public: 00888867034709
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: BIO-COMPRESSION SCREW 2.7 X 20MM
• Device Catalogue Number: AR-5025B-20
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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