MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-26 for IN-SITU BENDING & TWISTING HANDLE/STRAIGHT 03.100.091 manufactured by Synthes Gmbh.
[15019560]
Synthes (b)(4) sales consultant reported: the in-situ bending and twisting handle/straight was being used insitu to bend a low-profile pelvic plate. With intense torque, the tip of the bender broke off the end of the instrument. The surgery was completed with a like instrument. This is 1 of 1 report for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15335218]
This device used for treatment and not diagnosis. A device history records review has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05665 |
| MDR Report Key | 3538354 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-26 |
| Date of Report | 2013-11-29 |
| Date Mfgr Received | 2013-11-29 |
| Date Added to Maude | 2014-04-02 |
| 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 | IN-SITU BENDING & TWISTING HANDLE/STRAIGHT |
| Product Code | HXP |
| Date Received | 2013-12-26 |
| Catalog Number | 03.100.091 |
| Lot Number | T977943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-12-26 |