MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-25 for BONECURETTE RECTANG 6*9 L250 389.023 manufactured by Synthes Gmbh.
[3516387]
It was reported that the bone curette broke at the blade. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10753608]
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. (b)(6). A review of the dhr for this lot has been requested. The additional evaluation revealed that the blade was broken due to a mechanical overload.
Patient Sequence No: 1, Text Type: N, H10
[26178350]
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 history record review results: manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-02749 |
| MDR Report Key | 3187058 |
| Report Source | 01,07 |
| Date Received | 2013-06-25 |
| Date of Report | 2012-05-18 |
| Date Mfgr Received | 2013-06-25 |
| Device Manufacturer Date | 1999-07-22 |
| Date Added to Maude | 2013-09-17 |
| 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 | LINDA PLEWS |
| 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 | BONECURETTE RECTANG 6*9 L250 |
| Product Code | HTF |
| Date Received | 2013-06-25 |
| Catalog Number | 389.023 |
| Lot Number | 1008 |
| 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 | 2013-06-25 |