FDA Adverse Event
Malfunction
Summary report: N
DRIVER SHAFT, T6, SELF RETAINING, AO
MDR report key: 23466832
·
Received November 4, 2025
Report
- Report Number
- 1220246-2025-04995
- Event Type
- Malfunction
- Date Received
- November 4, 2025
- Date of Event
- October 27, 2025
- Report Date
- January 2, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867385566
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H3, H6 THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED (B)(4) BATCH 1392503 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE HEX'S TIP WAS TWISTED. A FUNCTIONAL TEST CANNOT BE PERFORMED AS THE INSTRUMENT WAS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SPECIFICALLY THE APPLICATION OF EXCESSIVE TORQUE FORCE DURING USE.
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem · 0
ON 10/27/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVE SHAFT IS TWISTED AT THE TIP. NOTICED DURING A CASE, SWAPPED, AND COMPLETED WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2815553 | DRIVER SHAFT, T6, SELF RETAINING, AO | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | DRIVER SHAFT, T6, SELF RETAINING, AO | 1392503 | 00888867385566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |