FDA Adverse Event
Malfunction
Summary report: N
DW ARTHROSCOPY FLUID MANAGEMENT DEV
MDR report key: 19569321
·
Received June 19, 2024
Report
- Report Number
- 1220246-2024-06185
- Event Type
- Malfunction
- Date Received
- June 19, 2024
- Date of Event
- August 25, 2021
- Report Date
- June 19, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRX
- UDI-DI
- 00888867039377
- PMA / PMN Number
- K083707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS NOT CONFIRMED. THE UNIT PASSED ALL TESTS. SEE ATTACHED EVALUATION.
Description of Event or Problem · 0
ON 8/25/2021 IT WAS REPORTED BY SALES REPRESENTATIVE VIA SEMS THAT AR-6480 DW ARTHROSCOPY FLUID MANAGEMENT DEV IS NOT CONSISTENTLY WORKING, INTERMITTENT FUNCTION. THIS WAS DISCOVERED DURING A PROCEDURE, NO PATIENT AFFECTED; NO FURTHER DETAILS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702468 | DW ARTHROSCOPY FLUID MANAGEMENT DEV | ARTHROSCOPE AND ACCESSORIES | HRX | ARTHREX, INC. | DW ARTHROSCOPY FLUID MANAGEMENT DEV | 10052342 | 00888867039377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |