FDA Adverse Event
Malfunction
Summary report: N
DRIVER SHAFT, T8, SELF RETAINING, AO
MDR report key: 23744417
·
Received December 8, 2025
Report
- Report Number
- 1220246-2025-05486
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- November 14, 2025
- Report Date
- March 23, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867316270
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS, SUCH AS OVER-TORQUING THE DEVICE WITH EXCESSIVE FORCE.
Description of Event or Problem · 0
ON 11/19/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18700-54 T8 SELF-RETAINING DRIVER SHAFT TIP BROKE OFF IN THE HEAD OF A 2.4 SCREW DURING A PROXIMAL PHALANX FRACTURE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2447747 | DRIVER SHAFT, T8, SELF RETAINING, AO | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | DRIVER SHAFT, T8, SELF RETAINING, AO | 1392407 | 00888867316270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |