EASY-OUT, MICRO COMPRESSION FT
Report
- Report Number
- 1220246-2025-09227
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 10, 2024
- Report Date
- February 12, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867263802
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
CORRECTION: H1 TO N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON RECEIVING ADDITIONAL INFORMATION FROM THE FIELD THAT CLARIFIED THE EVENT, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803. ADDITIONAL INFORMATION: B5, H3, H6.
ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-61 SCREW REMOVER, EASY-OUT, 2.5 MICRO COMPRESSION FT HAD THE TIP BREAK (FROM THEIR HEADLESS COMPRESSION SCREW SET #3). THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION WAS RECEIVED ON 01/21/2025: THE DEVICE DID NOT BREAK IN THE PATIENT. THE PIECE BROKE ON THE BACK TABLE AFTER USE. ALL FRAGMENTS WERE OBTAINED. THE CASE WAS COMPLETED BY REMOVING THE SCREW WITH THE SCREW REMOVER. THE SCREW REMOVER THEN BROKE OFF AFTER THE SCREW WAS REMOVED. THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING HARDWARE REMOVAL ON (B)(6) 2025, WITH NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382624 | EASY-OUT, MICRO COMPRESSION FT | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | EASY-OUT, MICRO COMPRESSION FT | 1391932 | 00888867263802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |