FDA Adverse Event
Malfunction
Summary report: N
.062 WIRE CUTTER W/ SAFTY INSRT, ANGLED
MDR report key: 21481422
·
Received February 27, 2025
Report
- Report Number
- 1220246-2025-00733
- Event Type
- Malfunction
- Date Received
- February 27, 2025
- Date of Event
- February 19, 2025
- Report Date
- May 30, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- 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.
Additional Manufacturer Narrative · 0
COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE SILICONE INSERTERS WERE REMOVED AND ONE OF THE JAWS WAS BROKEN OFF. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO USER ERROR DUE TO EXCESSIVE PRESSURE USED TO CUT THE WIRE.
Description of Event or Problem · 0
ON 02/19/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER WAS BROKEN. THIS OCCURRED DURING A CASE THERE WERE NO ADVERSE AFFECTS ON THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1286189 | .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED | 672331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |