FDA Adverse Event
Malfunction
Summary report: N
DJO SURGICAL
MDR report key: 23472674
·
Received November 4, 2025
Report
- Report Number
- 1644408-2025-01512
- Event Type
- Malfunction
- Date Received
- November 4, 2025
- Date of Event
- October 7, 2025
- Report Date
- March 14, 2026
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- HWX
- UDI-DI
- 00190446839200
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2025-01060; 804-06-318, S303-BROKE/CRACKED/DAMAGED, REVISION SURGERY. 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
IT WAS REPORTED THAT THE CANNULATED TAP WAS ADVANCE OVER WIRE AND STARTED TO ADVANCE. THEN THE TAP STARTED SPINNING FREELY AND THE TIP OF THE TAP HAD BROKEN OFF INSIDE GLENOID. THE BROKEN PART WAS REMOVED BUT THIS CAUSED 20 MINUTES DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2607686 | DJO SURGICAL | ALTIVATE REVERSE GLENOID CANNULATED TAP, 6.5MM | HWX | ENCORE MEDICAL L.P. | 088237 | 00190446839200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |