MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.5MM HEX, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 12-jan-2026, it was reported by a sales representative via (b)(4) that an ar-8737-37 1.5 mm hex, cannulated driver shaft broke off in the screw.It was reported that during a metacarpal fracture repair procedure, before inserting the 2.5mm compression ft screw, the surgeon drilled the full length of the screw with the 2.0mm drill.Upon insertion, the surgeon had difficulty advancing the screw past the isthmus where the fracture site was located.He backed the screw out, re-drilled and tried to reinsert the screw.After getting threads across the fracture site, a click was heard when he tried to continue advancing the screw.The driver was removed and it was determined that the driver shaft had broken off in the screw.The comp ft screw was removed, and the case was completed with a plate and screws.The case was completed successfully with no patient harm, no piece(s) broke off in the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 1.5MM HEX, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24245306
• Report Number: 1220246-2026-00366
• Device Sequence Number: 15945055
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: (01)00888867127159(11)230928(10)1392338
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/13/2026

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1392338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Distributor Facility Aware Date: 01/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown