MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-27 for PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE 399.350-EXS manufactured by Synthes Gmbh.
[11060678]
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. Manufacturing documents were reviewed and no complaint related issues were found. Reported date: (b)(4) 2012. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[21655131]
It was reported that the instruments have rust. This is report 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21906406]
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. The evaluation revealed that the traces visible on the surface consist not only of rust, but also of organic residue. We suspect that these deposits formed out of residue from the cleaning and sterilization process. It can be said in general regarding rust formation that all materials, including so-called rust-free steel metals, are only conditionally rust-resistant. Please note that these items require special care. They will be rust resistant only as long as they are immediately dried and placed in dry storage. No product defect was able to be found. However, a review of the device history records has been requested. Device is not distributed in the united states, but is similar to device marketed in the usa.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-04114 |
| MDR Report Key | 3192512 |
| Report Source | 01,07 |
| Date Received | 2013-06-27 |
| Date of Report | 2012-08-28 |
| Date Mfgr Received | 2013-07-08 |
| Device Manufacturer Date | 2010-07-19 |
| Date Added to Maude | 2013-09-20 |
| 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 | PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE |
| Product Code | HTE |
| Date Received | 2013-06-27 |
| Returned To Mfg | 2012-10-22 |
| Catalog Number | 399.350-EXS |
| Lot Number | 5906717 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2013-06-27 |