MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-04-23 for CABLE CRIMPER 391.882 manufactured by Synthes Monument.
[1582062]
During a hip revision procedure, the surgeon had replaced the stem of the total hip and the pt experienced a proximal femur fracture. Surgeon was attempting to use a 1. 0mm ti cable with crimp and the cable crimper. The crimper would not hold and kept sliding off the crimp. When the surgeon could not crimp the cables with the crimper, he attempted to use a competitive device which also did not crimp the cables. The procedure was extended at least one hr. The surgeon completed the procedure using arthrex fiber wire.
Patient Sequence No: 1, Text Type: D, B5
[8543884]
Additional info has been requested. Subject device is an instrument and is not implanted. Investigation could not be concluded, no conclusion could be drawn. No device has been returned. Review of the mfg records will be requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2010-00074 |
| MDR Report Key | 1667808 |
| Report Source | 05,07 |
| Date Received | 2010-04-23 |
| Date of Report | 2010-04-07 |
| Date of Event | 2010-04-07 |
| Date Mfgr Received | 2010-04-07 |
| Device Manufacturer Date | 2002-07-23 |
| Date Added to Maude | 2011-02-22 |
| 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 | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE. |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE CRIMPER |
| Generic Name | CABLE CRIMPER |
| Product Code | HXS |
| Date Received | 2010-04-23 |
| Model Number | NA |
| Catalog Number | 391.882 |
| Lot Number | P508134 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-23 |