FDA Adverse Event
Malfunction
Summary report: N
UNIVERS II VER ROD BRACKET FOR BROACH
MDR report key: 24618227
·
Received March 17, 2026
Report
- Report Number
- 1220246-2026-01458
- Event Type
- Malfunction
- Date Received
- March 17, 2026
- Date of Event
- February 24, 2026
- Report Date
- March 17, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867137967
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9231-20 BRACKET WAS STRUCK WITH A MALLET WHEN REMOVING AND SNAPPED. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677271 | UNIVERS II VER ROD BRACKET FOR BROACH | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | UNIVERS II VER ROD BRACKET FOR BROACH | 012244 | 00888867137967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |