FDA Adverse Event
Malfunction
Summary report: N
T15 HEXALOBE, ISO, CANN.
MDR report key: 23246847
·
Received October 8, 2025
Report
- Report Number
- 1220246-2025-04511
- Event Type
- Malfunction
- Date Received
- October 8, 2025
- Date of Event
- September 30, 2025
- Report Date
- October 29, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 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 CAN BE ATTRIBUTED MISUSE DUE TO MISALIGNED INSERTION; OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.
Description of Event or Problem · 0
ON 09/30/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. 2) AR-8750-03 T15 HEXALOBE DRIVER SHAFTS BROKE DURING SURGERY, AND NO PATIENT WAS AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2513346 | T15 HEXALOBE, ISO, CANN. | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T15 HEXALOBE, ISO, CANN. | 1392406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |