FDA Adverse Event
Malfunction
Summary report: N
LABRAL SCORPION
MDR report key: 19079196
·
Received April 10, 2024
Report
- Report Number
- 1220246-2024-01942
- Event Type
- Malfunction
- Date Received
- April 10, 2024
- Date of Event
- January 15, 2021
- Report Date
- April 10, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867015999
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. LABRAL SCORPION HAND INSTRUMENT WAS ETCHED WITH MULTIFIRE SCORPION SL ON TOP OF THE HANDLE. RELATED ETCHING DOES NOT PERTAIN TO A LABRAL SCORPION HAND INSTRUMENT AND WAS ETCHED INCORRECTLY. PLEASE SEE AGILE PRINT AR-13998. FOR CORRECT ETCHING AND SPECIFICATION. PLEASE REFER TO CAPA-00278.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE AR-13998 WAS RECEIVED HAVING ¿FASTPASS SCORPION SL¿ ETCHED ON THE TOP OF THE HANDLE INSTEAD OF ¿LABRAL SCORPION¿ AS PREVIOUSLY SEEN ON OLDER DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135903 | LABRAL SCORPION | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | LABRAL SCORPION | 11818720 | 00888867015999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |