MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 50MM LGTH; BONE FIXATION PLATE

Model Number	COMPR FT SCRW, 5.0 LG, 50MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/02/2024
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 10/16/2024, it was reported by a sales representative via (b)(4) that an ar-8750-03 driver shaft, t15 hexalobe, cannulated had the tip of the screw break off in the head of the screw when the surgeon was trying to back out the screw.The case was completed successfully, with no pieces breaking off inside the patient.This was discovered during a hardware removal procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 11/04/2024: there was no case delay.The hardware removal procedure was for the removal of the arthrex part ar-8750-50h 5.0 large compression ft screw, which was explanted during the surgery.At this time, it is unknown why the patient underwent revision surgery.No arthrex products were implanted during this surgery.
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: COMPR FT SCRW, 5.0 LG, 50MM LGTH
• Common Device Name: BONE FIXATION 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: 20642248
• Report Number: 1220246-2024-08491
• Device Sequence Number: 7432349
• Product Code: HRS
• UDI-Device Identifier: 00888867262966
• UDI-Public: 00888867262966
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: COMPR FT SCRW, 5.0 LG, 50MM LGTH
• Device Catalogue Number: AR-8750-50H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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