FDA Adverse Event
Malfunction
Summary report: N
1.5MM TI CORTEX SCREW SELF-TAPPING 11MM
MDR report key: 3220871
·
Received July 11, 2013
Report
- Report Number
- 2520274-2013-04190
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 19, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- MQN
- PMA / PMN Number
- K981275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS AN UNSPECIFIED FINGER SURGERY. TWO 1.5MM SELF TAPPING TITANIUM CORTEX SCREW HEADS SNAPPED OFF AND THE SHAFTS REMAIN IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319486 | 1.5MM TI CORTEX SCREW SELF-TAPPING 11MM | MQN | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |