MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-02-28 for BONE CURETTE-ANGLED 689.672 manufactured by Synthes Gmbh.
[3300310]
It was reported that the instrument resin handles are leaching brown from the handle. This is 4 of 10 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[10678873]
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 filing this report shall be filed on a supplemental mdr. The sample was received in good condition. The instrument corresponds to drawings and processes according to manufacturing requirements. Discoloration was not found on the instrument. Measurable dimensions were found within tolerance. A review od the device history record did not show conditions that could have contributed to the reported event. This complaint is invalid from a manufacturing perspective.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10306 |
| MDR Report Key | 3003339 |
| Report Source | 06,07 |
| Date Received | 2013-02-28 |
| Date of Report | 2011-05-06 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 2013-05-08 |
| 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 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| 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 | BONE CURETTE-ANGLED |
| Product Code | HTF |
| Date Received | 2013-02-28 |
| Returned To Mfg | 2011-05-23 |
| Catalog Number | 689.672 |
| Lot Number | A7HA13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-28 |