FDA Adverse Event
Malfunction
Summary report: N
T10 HEXALOBE, CMP FT
MDR report key: 24792054
·
Received April 6, 2026
Report
- Report Number
- 1220246-2026-01961
- Event Type
- Malfunction
- Date Received
- April 6, 2026
- Date of Event
- March 12, 2026
- Report Date
- May 20, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867127166
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: D9, G3, H3, H6 ONE UNPACKAGED AR-8737-38 T10 HEXALOBE DRIVER, BATCH 5038841, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE TIP OF THE DEVICE WAS TWISTED AND FRACTURED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-RELATED FACTORS SUCH AS EXCESSIVE TORQUE APPLICATION. THE COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE INVESTIGATION PHOTOS.
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 12-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8737-38 T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47419 | T10 HEXALOBE, CMP FT | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T10 HEXALOBE, CMP FT | 5038841 | 00888867127166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |