FDA Adverse Event
Malfunction
Summary report: N
DRILL GUIDE FOR DIAM 3.5 SCREW
MDR report key: 2122073
·
Received May 24, 2011
Report
- Report Number
- 9615741-2011-00023
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 24, 2011
- Manufacturer
- INTEGRA, SAINT PRIEST
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE DRILL GUIDE BROKE WHEN BEING UNSCREWED WITH THE SCREWDRIVER DURING A SURGICAL PROCEDURE. NO EXCEPTIONAL FORCE WAS BEING APPLIED AT THE TIME OF THE BREAKAGE. THERE WAS NO ADVERSE OUTCOME FOR THE PT AND NO SIGNIFICANT INCREASE IN SURGERY TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL GUIDE FOR DIAM 3.5 SCREW | ADVANSYS | HTW | INTEGRA, SAINT PRIEST | EJB3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |