FDA Adverse Event
Malfunction
Summary report: N
BONELEVER SMALL SHORT NARROW TIP W/6 L16
MDR report key: 2820606
·
Received October 5, 2012
Report
- Report Number
- 8030965-2012-00983
- Event Type
- Malfunction
- Date Received
- October 5, 2012
- Report Date
- September 7, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION HAS SHOWN THAT BOTH BONE LEVERS ARE CONTAMINATED WITH REDDISH BROWN RESIDUES WHICH COULD EASILY BE REMOVED BY BRUSHING. NO MANUFACTURING RELATED ISSUES COULD BE FOUND. WE CONCLUDE THAT THIS OCCURRENCE IS DUE TO AN IMPROPER REPROCESSING.
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
HOSPITAL IN (B)(6) REPORTED THAT THERE IS RUST ON THE INSTRUMENTS. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONELEVER SMALL SHORT NARROW TIP W/6 L16 | BONELEVER SMALL SHORT NARROW TIP W/6 L16 | HSB | SYNTHES GMBH | 3797161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |