FDA Adverse Event
Malfunction
Summary report: N
ELITE STRAIGHT ATTACHMENT
MDR report key: 17469015
·
Received August 7, 2023
Report
- Report Number
- 17469015
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- August 2, 2023
- Report Date
- August 3, 2023
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE STRYKER DRILL (SET 018) WAS GETTING HOT AND ¿CHATTERING¿ IN OR (OPERATING ROOM) THIS AFTERNOON. THE PERFORATOR ATTACHMENT WORKED FINE, BUT WHEN THE TEAM SWITCHED TO THE BLACK DRILL ATTACHMENT (REF# 5407-120-450) THAT IS WHEN THE NOISE AND DRILL STARTED TO HEAT UP PER THE SURGICAL TEAM. THE SURGEON WAS DONE USING THE DRILL AT THIS POINT IN THE PROCEDURE, SO A NEW DRILL WAS NOT OPENED TO THE FIELD. THE DRILL AND ATTACHMENT WERE BOTH TAGGED AND SET ASIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671510 | ELITE STRAIGHT ATTACHMENT | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS | 5407-120-450 | 2300607603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20805 DA | Female |