MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-12-21 for TROCAR HOLDER F/03.606.020 03.606.021 manufactured by Synthes Gmbh.
[3099953]
Device report from synthes (b)(4) reports an event in (b)(6) as follows. The threaded part of the trocar holder was broken off. The cause of the breakage at the junction of 2 parts was reported to be unknown.
Patient Sequence No: 1, Text Type: D, B5
[10386298]
Device was used for treatment, not diagnosis. The investigation is ongoing; no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-01637 |
| MDR Report Key | 2883689 |
| Report Source | 01,07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-23 |
| Date of Event | 2012-11-15 |
| Date Mfgr Received | 2012-11-23 |
| Device Manufacturer Date | 2008-09-19 |
| Date Added to Maude | 2013-03-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY BROWN |
| 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 HOLDER F/03.606.020 |
| Generic Name | TROCAR HOLDER F/03.606.020 |
| Product Code | KTE |
| Date Received | 2012-12-21 |
| Returned To Mfg | 2012-12-10 |
| Catalog Number | 03.606.021 |
| Lot Number | 1985808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-12-21 |