FDA Adverse Event
Malfunction
Summary report: N
REVERS LEVER-LOCKING BROACH HANDLE
MDR report key: 23691624
·
Received December 2, 2025
Report
- Report Number
- 1220246-2025-05296
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- November 10, 2025
- Report Date
- December 2, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867290464
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 11/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 REVERS LEVER-LOCKING BROACH HANDLE AND AN AR-9510-01 UNIVERS REVERS VERSION ROD EXPERIENCED AN ISSUE. WHEN USED TO BROACH, THE VERSION ROD AR-9510-01 SNAPPED OFF OF THE BROACH HANDLE AND WAS STUCK IN THE AR-9510-2. IT WOULD NOT THREAD BACK INTO THE SPOT IT NEEDS TO BE IN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1899583 | REVERS LEVER-LOCKING BROACH HANDLE | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | REVERS LEVER-LOCKING BROACH HANDLE | 170803-RW | 00888867290464 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |