MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-20 for CHISEL BOX CUTTING H5 03.820.122 manufactured by Synthes Gmbh.
[3517736]
It was reported that the chisels are rusty. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10746577]
Additional narrative: 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 evaluation revealed that inspection of the two chisels included in this complaint reveals that the visible traces on the surface are not only composed of rust but also include organic residues. We suspect that these deposits are due to residues left behind after the cleaning and sterilization process. In regard to rust formation, it can be generally stated that all materials, even so-called rust-free steel, is only rustproof to a certain extent. The material remains rustproof only as long as it is always dried immediately and stored in a dry place. No product defect was detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03404 |
| MDR Report Key | 3180689 |
| Report Source | 01,07 |
| Date Received | 2013-06-20 |
| Date of Report | 2011-06-06 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2008-03-26 |
| Date Added to Maude | 2013-09-13 |
| 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 | CHISEL BOX CUTTING H5 |
| Product Code | EML |
| Date Received | 2013-06-20 |
| Returned To Mfg | 2011-06-10 |
| Catalog Number | 03.820.122 |
| Lot Number | T920728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-06-20 |