FDA Adverse Event
Malfunction
Summary report: N
LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL
MDR report key: 23004612
·
Received September 9, 2025
Report
- Report Number
- 1220246-2025-03775
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- August 15, 2025
- Report Date
- December 19, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRS
- UDI-DI
- 00888867313231
- PMA / PMN Number
- K191326
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
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. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREP AND/OR SHALLOW DRIVER ENGAGEMENT DEPTH.
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) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07039383 THAT AN AR-18716-11 AND A AR-18716-10 LOW PROFILE SCREWS BROKE WHILE BEING IMPLANTED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1915191 | LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL | BONE FIXATION PLATE | HRS | ARTHREX, INC. | LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL | 00888867313231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |