FDA Adverse Event
Malfunction
Summary report: N
DJO SURGICAL
MDR report key: 23257179
·
Received October 9, 2025
Report
- Report Number
- 1644408-2025-01456
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- September 11, 2025
- Report Date
- February 18, 2026
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- FZX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-00272; 804-06-056, S303 - BROKE/CRACKED/DAMAGED, INSTRUMENT FAILURE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Additional Manufacturer Narrative · 0
ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE TIP OF THE STEM INSERTER SCREW BROKE OFF INSIDE THE STEM DURING IMPLANTATION INTO THE PATIENT. THE BROKEN TIP WAS NOT RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2609801 | DJO SURGICAL | ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD | FZX | ENCORE MEDICAL L.P. | 330408L01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other |