FDA Adverse Event
Malfunction
Summary report: N
APPLICATOR INNER SHAFT
MDR report key: 2973882
·
Received February 22, 2013
Report
- Report Number
- 8030965-2013-00600
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Report Date
- January 25, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 1
DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE BALL OF THE INNER SHAFT IS REALLY BROKEN OFF AT THE UPPER END. THERE ARE ALSO SIGNS OF WEAR AND TEAR VISIBLE IN THE FRONT AREA. WE ASSUME THAT HIGH MECHANICAL LOAD HAS LEAD TO THE FINAL BREAKAGE OF THE BALL. (B)(4).
Description of Event or Problem · 1
A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: KNOB AT THE END OF THE APPLICATOR SHAFT IS BROKEN OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78839 | APPLICATOR INNER SHAFT | APPLICATOR INNER SHAFT | LXH | SYNTHES GMBH | 3699912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |