FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20274343
·
Received September 20, 2024
Report
- Report Number
- 1644408-2024-01509
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- August 23, 2024
- Report Date
- December 11, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- PHX
- UDI-DI
- 00888912024617
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 D3, G1, H6, AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-00119; 508-00-001-10, S801 - DEVICE CRACKED/BROKE, COMPLAINT. 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
REVISION SURGERY - DUE TO WHEN INSERTING THE SET SCREW INTO THE GLENOSPHERE WITH THE RED HANDLE TORQUE SCREWDRIVER THE SCREW BROKE OFF HALFWAY. BROKEN/FRAGMENTED PIECES LEFT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1441087 | DJO SURGICAL | SCREW, RETAINING GLENOID HEAD RSP | PHX | ENCORE MEDICAL L.P. | UNKNOWN | 00888912024617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |