FDA Adverse Event
Malfunction
Summary report: N
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
MDR report key: 3576933
·
Received January 15, 2014
Report
- Report Number
- 2520274-2014-00231
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Report Date
- December 19, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING LOCATION CHANGED FROM SYNTHES (B)(4) TO SYNTHES USA. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PLACEHOLDER.
Description of Event or Problem · 1
MAUDE EVENT REPORT NO. (B)(4), DATED (B)(6) 2013 WAS RECEIVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40156 | CANNULATED 4.0MM HEXAGONAL SCREWDRIVER | HXX | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |