FDA Adverse Event
Malfunction
Summary report: N
45° DRILLING ATTACHMENT AO/ASIF COUPLING FOR PEN DRIVE
MDR report key: 3031195
·
Received April 2, 2013
Report
- Report Number
- 8030965-2013-01295
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- DZI
- PMA / PMN Number
- K043310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(4). THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION.
Description of Event or Problem · 1
FACILITY REPORTS DEVICE WAS USED DURING HAND SURGERY ON (B)(6) 2013 BUT WAS DETERMINED TO BE NOT WORKING. FACILITY CONTACT HAD NO INFORMATION REGARDING THE DEFICIENCY OF THE DEVICE OTHER THAN IT IS NOT WORKING. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134239 | 45° DRILLING ATTACHMENT AO/ASIF COUPLING FOR PEN DRIVE | DZI | SYNTHES GMBH | 3473100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |