FDA Adverse Event
Malfunction
Summary report: N
ACTIVE ADAPTIVE
MDR report key: 20670007
·
Received November 12, 2024
Report
- Report Number
- 3007593722-2024-00017
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 10, 2024
- Report Date
- August 13, 2025
- Manufacturer
- MEDSHAPE, INC.
- Product Code
- HSB
- UDI-DI
- M97022002900000
- PMA / PMN Number
- D155711
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Description of Event or Problem · 0
COMPLAINT - DYNANAIL JIG MIS-CALIBRATED / NOT ALIGNED AND CAUSED SCREW INSERTION ISSUES. PA SCREW MISSED NAIL AND TIBIAL SCREWS MORE DIFFICULT TO PLACE.PA SCREW MISSED AND NEEDED TO BE REMOVED. PA SCREW ARM LATER DROPPED AND DOC FREE HANDED NEW HOLE. TIBIAL SCREW HOLES DIDN'T LINE UP EITHER." THIS RESULTED IN A 30 MIN DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1644937 | ACTIVE ADAPTIVE | FRAME ASSEMBLY, CF, DYNANAIL | HSB | MEDSHAPE, INC. | 01701-03 | M97022002900000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |