FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT
MDR report key: 2970809
·
Received February 20, 2013
Report
- Report Number
- 2520274-2013-01024
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- September 30, 2009
- Report Date
- March 24, 2010
- Manufacturer
- SYNTHES
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE THE DRILL GUIDE TIP BROKE OFF WHILE IN USE. THERE WAS A SINGLE PIECE AND THIS PIECE WAS SUCCESSFULLY RETRIEVED BY THE SURGEON AND CONFIRMED BY C ARM X-RAY. THERE WAS NO INJURY TO THE PATIENT OR EXTENSION OF LENGTH OF STAY. THIS PIECE OF EQUIPMENT BELONGS TO THE REPRESENTATIVE AND IS BROUGHT INTO THE FACILITY FOR THE CASES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74266 | DRILL BIT | HTW | SYNTHES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |