FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE RESECT PROTECTOR,SZ L/50.0MM
MDR report key: 19382160
·
Received May 23, 2024
Report
- Report Number
- 1220246-2024-03736
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- March 3, 2023
- Report Date
- May 23, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867060388
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. COMPLAINT IS CONFIRMED. UPON VISUAL EVALUATION, OXIDATION/DISCOLORATION WAS OBSERVED ON BOTH SIDES OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.
Description of Event or Problem · 0
IT WAS REPORTED ON 03/03/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9221AG DRILL IS BENT, AR-9628 TIP IS BROKEN, AND AR-9401-40, AR-9401-46, AR-9401-50 RESECT PROTECTOR ARE RUSTY. CASE INVOLVEMENT, NO PATIENT EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604281 | ECLIPSE RESECT PROTECTOR,SZ L/50.0MM | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | ECLIPSE RESECT PROTECTOR,SZ L/50.0MM | 051888 | 00888867060388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |