FDA Adverse Event
Malfunction
Summary report: N
BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM
MDR report key: 2867575
·
Received December 11, 2012
Report
- Report Number
- 8030965-2012-01528
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Report Date
- November 5, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Additional Manufacturer Narrative · 1
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
THE TRIGGER IS JAMMING ON THE BATTERY HANDPIECE. AFTER CLEANING A BROWN SUBSTANCE THAT APPEARS TO BE MUD COMES OUT OF THE TRIGGER. AFTER STERILIZATION AND CLEANING THE BROWN MUD-LIKE SUBSTANCE WAS NOT DETECTED. THE DEVICE WAS CLEAN ON THE INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM | BATTERY HANDPIECE/MODULAR FOR TRAUMA RECON SYSTEM | HWE | SYNTHES GMBH | 5597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |