FDA Adverse Event
Malfunction
Summary report: N
DJO SURGICAL
MDR report key: 22745625
·
Received August 7, 2025
Report
- Report Number
- 1644408-2025-01117
- Event Type
- Malfunction
- Date Received
- August 7, 2025
- Date of Event
- July 10, 2025
- Report Date
- December 8, 2025
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- UDI-DI
- 00190446843818
- PMA / PMN Number
- K233481
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, 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.
Additional Manufacturer Narrative · 0
SEE H6 AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2025-00204; 804-06-310, S100 - FUNCTIONAL, INSTRUMENT FAILURE; SURGICAL - QUALITY COMPLAINTS. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem · 0
INSTRUMENT FAILURE - REAMER BINDED WHILE WE WERE REAMING AND SURGEON BELIEVES IT CAUSED A CRACK IN THE GLENOID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1497850 | DJO SURGICAL | ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE | KWS | ENCORE MEDICAL L.P. | 439754L01 | 00190446843818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Other |