FDA Adverse Event
Malfunction
Summary report: N
FASTPASS SCORPION, SL-MF
MDR report key: 19175043
·
Received April 24, 2024
Report
- Report Number
- 1220246-2024-02333
- Event Type
- Malfunction
- Date Received
- April 24, 2024
- Date of Event
- May 25, 2021
- Report Date
- April 24, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867090590
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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 RELATED CONDITION OF A BENT FORK ON THE DISTAL END OF THE TIP WAS CAUSED DUE TO MISUSE. THE MATING PART (NEEDLE) WAS NOT RETURNED. USED AN AR-13991N/LOT#401034 NEEDLE DURING EVALUATION. FUNCTION TEST DID NOT MEET THE FUNCTION CRITERIA DUE TO THE RELATED CONDITION.
Description of Event or Problem · 0
IT WAS REPORTED DURING A SHOULDER PROCEDURE THE TRIGGER MECHANISM ON THE AR-13999MF FASTPASS SCORPION, JAMMED CAUSING THE JAW NOT WORK PROPERLY. THE CASE WAS COMPLETE USING A SECOND AR-13999MF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1329346 | FASTPASS SCORPION, SL-MF | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | FASTPASS SCORPION, SL-MF | 64856 | 00888867090590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |