FDA Adverse Event
Malfunction
Summary report: N
INSTRUMENT CASE, UNIVERS VAULTLOCK GLEN
MDR report key: 19222610
·
Received May 1, 2024
Report
- Report Number
- 1220246-2024-02684
- Event Type
- Malfunction
- Date Received
- May 1, 2024
- Date of Event
- March 12, 2021
- Report Date
- May 1, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- MDM
- UDI-DI
- 00888867249752
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
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. COMPLAINT CONFIRMED. VISUAL INSPECTION IDENTIFIED CORROSION SPOTS INSIDE BOTH CADDIES. THE MOST LIKELY CAUSES OF THE EVENT IS REPEATED USE AND CLEANING CYCLES, IMPROPER CLEANING.
Description of Event or Problem · 0
IT WAS REPORTED BY THE AGENCY THAT THE FOLLOWING DEVICES ARE CORRODED: AR-9231-01PP QTY 1 AR-9231-02PP QTY 1 AR-9231-03PP QTY 1 AR-9231-04PP QTY 1 AR-9217CPP QTY 2 AR-9225CK QTY 1 AR-9225CP QTY 1
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2134639 | INSTRUMENT CASE, UNIVERS VAULTLOCK GLEN | MANUAL INSTR, GENERAL SURGICAL | MDM | ARTHREX, INC. | INSTRUMENT CASE, UNIVERS VAULTLOCK GLEN | 51098 | 00888867249752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |