FDA Adverse Event
Malfunction
Summary report: N
CANNULATED HEX SCREWDRIVER 2.5MM
MDR report key: 787147
·
Received November 22, 2006
Report
- Report Number
- 2027970-2006-00005
- Event Type
- Malfunction
- Date Received
- November 22, 2006
- Date of Event
- October 20, 2006
- Report Date
- October 25, 2006
- Manufacturer
- ARTHROTEK, INC.
- Product Code
- HXX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
HEX END OF SCREWDRIVER BROKE IN INTERFERENCE SCREW. ADDED 30 MINUTES TO CASE DUE TO HAVING TO RETRIEVE BROKEN PART. SCREWDRIVER WAS STUCK IN THE SCREW AND BROKE WHEN SURGEON PULLED DRIVER OUT OF WOUND SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED HEX SCREWDRIVER 2.5MM | HXX | HXX | ARTHROTEK, INC. | * | 039880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |