MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-05-10 for TROCAR ?4 GREEN 356.833 manufactured by Synthes Gmbh.
[3291328]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date, the distal screw repeatedly missed the nail. This caused a significant delay of the or time, greater than 20 percent. The surgeon changed the aiming arm for dynamic locking, and the screw could then be inserted. This is report 4 of 6 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10706389]
Device was used for treatment, not diagnosis. Device is not distributed in the united states, but is similar to a device marketed in the usa. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. Manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
[16504763]
Device was used for treatment, not diagnosis. The review of the manufacturing and material documents has shown that the instrument was manufactured to the specifications. A functional test has shown that the instrument functions properly. The review with function gages and test mandel showed no deviations. The complained failure could not be reproduced. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-02179 |
| MDR Report Key | 3105065 |
| Report Source | 01,07 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-04-17 |
| Date Mfgr Received | 2013-06-04 |
| Device Manufacturer Date | 2005-01-13 |
| Date Added to Maude | 2013-07-17 |
| 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 | ADAM SHUKUR |
| 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 | TROCAR ?4 GREEN |
| Product Code | KTE |
| Date Received | 2013-05-10 |
| Returned To Mfg | 2013-04-11 |
| Catalog Number | 356.833 |
| Lot Number | 2118381 |
| 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 | 2013-05-10 |