FDA Adverse Event
Malfunction
Summary report: N
TROCAR HOLDER F/03.606.020
MDR report key: 2883689
·
Received December 21, 2012
Report
- Report Number
- 8030965-2012-01637
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 23, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- KTE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS. THE THREADED PART OF THE TROCAR HOLDER WAS BROKEN OFF. THE CAUSE OF THE BREAKAGE AT THE JUNCTION OF 2 PARTS WAS REPORTED TO BE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCAR HOLDER F/03.606.020 | TROCAR HOLDER F/03.606.020 | KTE | SYNTHES GMBH | 1985808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |