MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-04 for GOUGE F/CANCELLOUS BONE GRAFT STRAIG W/1 399.620 manufactured by Synthes Gmbh.
[3494990]
It was reported that the instrument has never been used, but after sterilization at the hospital they discovered a spot at the top of instrument. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10792107]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. The additional evaluation revealed that there is indeed a discoloration mark on the inside of the cutting edge. Obviously the discoloration has not been spotted before sterilization. We can suppose that the tip was not dry enough and caused the discoloration/rust. Unfortunately we are not able to comprehend the mentioned problem. The manufacturing documents were reviewed and no discrepancies to the specifications were found. No product fault could be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-02588 |
| MDR Report Key | 3145813 |
| Report Source | 01,07 |
| Date Received | 2013-06-04 |
| Date of Report | 2011-02-22 |
| Date Mfgr Received | 2011-02-22 |
| Date Added to Maude | 2013-08-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOUGE F/CANCELLOUS BONE GRAFT STRAIG W/1 |
| Product Code | GDH |
| Date Received | 2013-06-04 |
| Catalog Number | 399.620 |
| Lot Number | 5906287 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-04 |