MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO, 50MM; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,2.5 MICRO, 50MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/15/2025, a sales representative reported via phone that an ar-8725-50h compression ft screw (from a loaner set) broke off inside the bone during insertion.The screw fractured approximately one-third of the way from the head, with about 35 mm embedded in the bone.The remaining portion of the screw was retrieved, while the embedded fragment was left in the bone.A k-wire was subsequently placed at the site.Additionally, during the procedure, the ar-8738s compression screw set (also from a loaner set) was found to be missing an ar-8737-61 screw remover, easy-out, 2.5 micro compression ft, and an ar-8737-59 screw remover, trephine/extractor, 2.5 micro/3.5 mini cft.Due to the absence of these two instruments, the screw could not be removed.The case was completed using non-arthrex k-wires to stabilize the fracture.The procedure was delayed by approximately 30 minutes, and whether additional anesthesia was administered is uncertain.This occurred during a metacarpal fracture procedure on (b)(6) 2025.
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 of the reported failure can be attributed to user error of the device due to improper bone prep and/or shallow driver engagement depth.

• Brand Name: COMPR FT SCRW,2.5 MICRO, 50MM
• 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: 22962821
• Report Number: 1220246-2025-03729
• Device Sequence Number: 9893870
• Product Code: HWC
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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
• Report Date (Section B): 12/19/2025

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 Model Number: COMPR FT SCRW,2.5 MICRO, 50MM
• Device Catalogue Number: AR-8725-50H
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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
• Patient Sex: Unknown