FDA Adverse Event
Malfunction
Summary report: N
.062 WIRE CUTTER W/ SAFTY INSRT, ANGLED
MDR report key: 20724008
·
Received November 19, 2024
Report
- Report Number
- 1220246-2024-08555
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- October 23, 2024
- Report Date
- August 21, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00841435109582
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE.
Description of Event or Problem · 0
ON 10/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER BROKE. THIS OCCURRED DURING A CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92653 | .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED | 672207 | 00841435109582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |