MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-26 for BOX CURETTE 03.605.003 manufactured by Synthes Gmbh.
[3169575]
Medwatch indicated: the tip of the synthes box curette broke. The tip of the synthes box curette was removed from the surgical site. Device was substituted with a new synthes box curette, and procedure was completed without further incident.
Patient Sequence No: 1, Text Type: D, B5
[10528627]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated (b)(4) 2012. Device (s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filling this report shall be filed on a supplemental mdr. No device history review or investigation could be performed, because no lot number was reported and the sample was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10360 |
| MDR Report Key | 2987182 |
| Report Source | 05,07 |
| Date Received | 2013-02-26 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2013-01-28 |
| Date Added to Maude | 2013-05-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 19880 |
| Manufacturer Country | US |
| Manufacturer Postal | 19880 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOX CURETTE |
| Product Code | HTF |
| Date Received | 2013-02-26 |
| Catalog Number | 03.605.003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |