FDA Adverse Event
Malfunction
Summary report: N
T15 HEXALOBE, ISO, CANN.
MDR report key: 25173374
·
Received May 14, 2026
Report
- Report Number
- 1220246-2026-02850
- Event Type
- Malfunction
- Date Received
- May 14, 2026
- Date of Event
- April 27, 2026
- Report Date
- May 14, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867263765
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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.
Description of Event or Problem · 0
ON 27-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 HEXALOBE FELL APART DURING USE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566189 | T15 HEXALOBE, ISO, CANN. | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T15 HEXALOBE, ISO, CANN. | 00888867263765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |