FDA Adverse Event
Malfunction
Summary report: N
PLATE CUTTER, HERCULES STYLE
MDR report key: 23450073
·
Received November 3, 2025
Report
- Report Number
- 1220246-2025-04946
- Event Type
- Malfunction
- Date Received
- November 3, 2025
- Date of Event
- October 27, 2025
- Report Date
- March 5, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- MDM
- UDI-DI
- 00888867055254
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT, ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE SUSTAINED OVER TIME IN THE FIELD. THE MANUFACTURING DATE IS 2020.
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 10/23/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8954-03 PLATE CUTTER TEETH BROKE DURING USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1067445 | PLATE CUTTER, HERCULES STYLE | WIRE CUTTER | MDM | ARTHREX, INC. | PLATE CUTTER, HERCULES STYLE | 711951 | 00888867055254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |