FDA Adverse Event
Malfunction
Summary report: N
SHAVER HP, APSII, HAND CONTROL
MDR report key: 23956908
·
Received January 5, 2026
Report
- Report Number
- 1220246-2026-00034
- Event Type
- Malfunction
- Date Received
- January 5, 2026
- Date of Event
- December 15, 2025
- Report Date
- February 13, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWE
- UDI-DI
- 00888867043237
- PMA / PMN Number
- K932699
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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: D9, G3, H3, H6. THE EVALUATION CONFIRMED THE REPORTED EVENT OF AR-8330H SHAVER'S WIRES ARE EXPOSED. THIS WAS ATTRIBUTED TO THE NORMAL WEAR AND TEAR OF THE SHP CABLE.
Description of Event or Problem · 0
ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330H SHAVER'S WIRES ARE EXPOSED. DISCOVERED AFTER THE CASE WITH NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20413 | SHAVER HP, APSII, HAND CONTROL | POWERED SURG ORTHOPEDIC INSTR | HWE | ARTHREX, INC. | SHAVER HP, APSII, HAND CONTROL | 12468453 | 00888867043237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |