FDA Adverse Event
Malfunction
Summary report: N
SUTRLASSO SD SFT,25°TIGHT LFT CRV,R
MDR report key: 24160493
·
Received January 23, 2026
Report
- Report Number
- 1220246-2026-00289
- Event Type
- Malfunction
- Date Received
- January 23, 2026
- Date of Event
- January 8, 2026
- Report Date
- May 15, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867035584
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem · 0
ON (B)(6) 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT SUTRLASSO SD SFT,45°RT CRV, R AR-5068-45R LOT 0072332 WAS BENT AND SUBSEQUENTLY BROKE DURING THE PROCEDURE PM (B)(6) 2026. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS USING A NEW (AR-5068-XX) WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND NO HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3106 | SUTRLASSO SD SFT,25°TIGHT LFT CRV,R | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | SUTRLASSO SD SFT,25°TIGHT LFT CRV,R | 0072320 | 00888867035584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |