FDA Adverse Event
Malfunction
Summary report: N
RUGGLES
MDR report key: 1848719
·
Received September 27, 2010
Report
- Report Number
- 1848719
- Event Type
- Malfunction
- Date Received
- September 27, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 27, 2010
- Manufacturer
- INTEGRA SURGICAL
- Product Code
- HAE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
Narratives
Description of Event or Problem · 1
PATIENT TO OR FOR RE-DO LAMINECTOMY WITH EVACUATION OF SPINAL ABSCESSES, COMPLETE DISCECTOMY AND EVACUATION OF DISC ABSCESS. SURGEON WAS ATTEMPTING TO CREATE A FORAMINOTOMY WITH A RUGGLES 2MM STRAIGHT RONGEUR WHEN THE TIP (ONE OF THE JAWS) OF THE INSTRUMENT BROKE OFF. THIS INSTRUMENT IS USED TO CUT BONE. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED AND INSTRUMENT AND BROKEN COMPONENT WERE REMOVED FROM FIELD. SURGEON OBTAINED A DIFFERENT INSTRUMENT TO COMPLETE THE REQUIRED PROCEDURE. ITEMS BAGGED AND SEQUESTERED FOR RISK MANAGEMENT. NO HARM TO PATIENT AS NOTED BY SURGEON. PROCEDURE FINISHED AND PATIENT TAKEN TO PACU FOR RECOVERY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================IT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUGGLES | RONGEUR, MANUAL, KERRISON | HAE | INTEGRA SURGICAL | RN5712H | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |