FDA Adverse Event
Malfunction
Summary report: N
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS
MDR report key: 3121497
·
Received May 21, 2013
Report
- Report Number
- 2520274-2013-02716
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Report Date
- April 22, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- PMA / PMN Number
- K000089
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A 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. THE BRAND NAME WAS CORRECTED FROM T25 LOCKING SCREWS TO 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS.
Additional Manufacturer Narrative · 1
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED. A COPY OF THE REPORT WILL BE INCLUDED WITH THIS REPORT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224038 | 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |