MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-17 for HOLDER F/VISIOS+FRA TRIAL-IMPL 397.089 manufactured by Synthes Gmbh.
[3551686]
It was reported that the inner part of 397. 089 broke while it was being placed in the trial implant 396. 453. The tip of the inner part of 397. 089 is now stuck in the trial implant. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10853987]
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. The additional evaluation revealed that the thread part of the inner shaft is broken. The thread part is stuck into visios trial implant. No manufacturing related conditions were found and we have to assume that the instrument was moved in cranial and caudal directions. The design of the holder for visios was planned for lateral movements to reduce the forces which were caused on the inner shaft. However, a review of the device history records has been requested.
Patient Sequence No: 1, Text Type: N, H10
[10989587]
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. A review of the device history records was performed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03230 |
| MDR Report Key | 3173890 |
| Report Source | 01,07 |
| Date Received | 2013-06-17 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-11-10 |
| Date Mfgr Received | 2013-06-20 |
| Device Manufacturer Date | 2009-10-13 |
| Date Added to Maude | 2013-09-11 |
| 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 | HOLDER F/VISIOS+FRA TRIAL-IMPL |
| Product Code | GDZ |
| Date Received | 2013-06-17 |
| Returned To Mfg | 2011-11-28 |
| Catalog Number | 397.089 |
| Lot Number | 3233260 |
| 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 | 2013-06-17 |