FDA Adverse Event
Malfunction
Summary report: N
SHAVER HP, SYNERGY, HANDCONTROL
MDR report key: 20181646
·
Received September 10, 2024
Report
- Report Number
- 1220246-2024-07494
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Date of Event
- August 20, 2024
- Report Date
- October 1, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWE
- UDI-DI
- 00888867123991
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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
(SHP CABLE) THE EVALUATION CONFIRMED THE REPORTED EVENT, AR-8332H SHAVER HAS EXPOSED WIRING ON THE CABLE." AND ATTRIBUTED IT TO USE ERROR.
Description of Event or Problem · 0
ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06641198 THAT AN AR-8332H SHAVER HAS EXPOSED WIRING ON THE CABLE. DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335387 | SHAVER HP, SYNERGY, HANDCONTROL | POWERED SURG ORTHOPEDIC INSTR | HWE | ARTHREX, INC. | SHAVER HP, SYNERGY, HANDCONTROL | 15043522 | 00888867123991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |