FDA Adverse Event
Summary report: N
AMIS BROACH HANDLE
MDR report key: 3185214
·
Received June 12, 2013
Report
- Report Number
- 3006639916-2013-00066
- Date Received
- June 12, 2013
- Date of Event
- May 15, 2013
- Report Date
- June 12, 2013
- Manufacturer
- MEDACTA USA INC.
- Product Code
- LZO
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE MOBILE PEG OF THE HANDLE 01.15.10.0131, WAS FOUND TO BE BROKEN. REF MFR NUMBER: 3005180920-2013-00066.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267004 | AMIS BROACH HANDLE | REUSABLE SURGICAL INSTRUMENT FOR HIP | LZO | MEDACTA USA INC. | 105840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |