FDA Adverse Event
Malfunction
Summary report: N
SHAVER HP, APSII, HAND CONTROL
MDR report key: 12953721
·
Received December 7, 2021
Report
- Report Number
- 1220246-2021-04056
- Event Type
- Malfunction
- Date Received
- December 7, 2021
- Date of Event
- November 17, 2021
- Report Date
- August 4, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- HWE
- UDI-DI
- 00888867043237
- PMA / PMN Number
- K932699
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ALTHOUGH THE DEVICE OPERATED TO SPECIFICATION, THE INVESTIGATION OF THE REPORTED EVENT OF 'AR-8330H SHP OVERHEATED' WILL BE CONSIDERED CONFIRMED BASED ON THE SURGEON'S COMMENTS AND ATTRIBUTED TO MISHANDLING.
Additional Manufacturer Narrative · 0
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA (B)(6) THAT AN AR-8330H SHP OVERHEATED. THIS WAS DISCOVERED DURING A CASE, THE SURGEON AND THE PATIENT WERE BOTH BURNED DURING THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1855491 | SHAVER HP, APSII, HAND CONTROL | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | ARTHREX, INC. | SHAVER HP, APSII, HAND CONTROL | 10323693 | 00888867043237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |