FDA Adverse Event
Malfunction
Summary report: N
REAMER 0ZZ F/PFNA BLADE
MDR report key: 2805884
·
Received October 5, 2012
Report
- Report Number
- 8030965-2012-00979
- Event Type
- Malfunction
- Date Received
- October 5, 2012
- Report Date
- September 6, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.
Additional Manufacturer Narrative · 1
(B)(4): THE MANUFACTURING AND RAW MATERIAL PAPERS WERE REVIEWED AND WERE FOUND TO BE IN SPECIFICATION. THE MEASURABLE DIMENSIONS MET SPECIFICATIONS. THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION. NO PRODUCT FAULT COULD BE DETECTED. (B)(4): PLACEHOLDER.
Description of Event or Problem · 1
A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE TIP OF THE INSTRUMENT IS DAMAGED. THE BROKEN PARTS HAVE BEEN DISPOSED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REAMER 0ZZ F/PFNA BLADE | REAMER 011 F/PFNA BLADE | HTO | SYNTHES GMBH | SX405493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |