FDA Adverse Event
Malfunction
Summary report: N
T15 HEXALOBE, ISO, CANN.
MDR report key: 20169434
·
Received September 9, 2024
Report
- Report Number
- 1220246-2024-07453
- Event Type
- Malfunction
- Date Received
- September 9, 2024
- Date of Event
- August 19, 2024
- Report Date
- June 17, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE CAN BE ATTRIBUTED TO USE ERROR DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.
Description of Event or Problem · 0
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06640569 THAT (2) AR-8750-03 DRIVER SHAFTS BROKE. THIS OCCURRED DURING USE IN A CASE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1536594 | T15 HEXALOBE, ISO, CANN. | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T15 HEXALOBE, ISO, CANN. | 1392420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |