MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-11-04 for BONECURETTE RECTANG 6*9 L250 389.023 manufactured by Synthes Gmbh.
[3902029]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: on the distal end of the curettes, it was noted the material is break off. This is 1 of 2 reports for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11376683]
This device used for treatment and not diagnosis. The manufacturing documents were reviewed and no complaint related issues were found. The device has been returned and the investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[26332299]
The visual investigation of the returned bone curette by the complaint handling unit noted damage on the distal end of the curette. The investigation has shown; that the instrument is a long time in strong use and the cutting edge is broken on one side. The review of the material and production history revealed that the instrument was manufactured according to the specifications. Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances. The complaint condition is likely the result of exceeding applied mechanical overload during use and a torsional move resulted to this damage. The complaint was determined to be invalid.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05168 |
| MDR Report Key | 3444912 |
| Report Source | 01,07 |
| Date Received | 2013-11-04 |
| Date of Report | 2013-10-09 |
| Date Mfgr Received | 2013-12-16 |
| Device Manufacturer Date | 2012-01-05 |
| Date Added to Maude | 2014-02-03 |
| 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 | SHERRY LAING |
| 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 | 2013-11-04 |
| Returned To Mfg | 2013-10-29 |
| Catalog Number | 389.023 |
| Lot Number | 7700849 |
| 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 | 2013-11-04 |