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 PERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/ 399.380 manufactured by Synthes Gmbh.
[10915349]
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. Dhr not available as device is older than 15 years. Correct manufacturing date from 04/18/2012 to 08/01/1990.
Patient Sequence No: 1, Text Type: N, H10
[18256127]
There was the start of oxidation at the transition from the steel part to the handle. This is 2 of 3 reports for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18402893]
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. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation has shown that it concerns very old instruments, which are more than 10 years old. The handles made from canvas are partially worn out and the shafts present discolorations. No manufacturing related issues were found and it is concluded that high temperature cycles during repeated sterilization processes have led to this occurrence. The lot number has been provided, a review of the device history record is not yet available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03704 |
| MDR Report Key | 3195002 |
| Report Source | 01,07 |
| Date Received | 2013-06-27 |
| Date of Report | 2012-04-18 |
| Date Mfgr Received | 2013-07-11 |
| Device Manufacturer Date | 1990-08-01 |
| 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 | PERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/ |
| Product Code | HTE |
| Date Received | 2013-06-27 |
| Catalog Number | 399.380 |
| Lot Number | 908 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |