MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-10-28 for TORQUE LIMITING HANDLE/QUICK RELEASE - 6MM HEX COUPLING 321.133 manufactured by Synthes Monument.
[19686067]
During an arcofix procedure, the surgeon was final tightening the gold locking screws with the torque limiting handle/quick release and the head of the screw sheared off in the center position. The head was retrieved with the shaft remaining in the bone and plate. Pt was augmented with posterior pedicle screw fixation and bone graft. The procedure was completed, surgeon noted the plate was locked in place. Torque limiting handle/quick release found to be out of specification due to lack of calibration.
Patient Sequence No: 1, Text Type: D, B5
[19747483]
This info was not provided during initial report. Additional info has been requested. Subject device is an instrument and is not implanted. Investigation is on going; no conclusion can be drawn as no device was returned. Review of the manufacturing records has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2010-00317 |
| MDR Report Key | 1888451 |
| Report Source | 05,07 |
| Date Received | 2010-10-28 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-07-05 |
| Date Mfgr Received | 2010-09-28 |
| Device Manufacturer Date | 2009-07-07 |
| Date Added to Maude | 2011-02-16 |
| 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 | CHARISSE BALL |
| 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 AVENUE |
| 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 | TORQUE LIMITING HANDLE/QUICK RELEASE - 6MM HEX COUPLING |
| Generic Name | TORQUE LIMITING HANDLE |
| Product Code | GFC |
| Date Received | 2010-10-28 |
| Model Number | NA |
| Catalog Number | 321.133 |
| Lot Number | 596692G08 |
| 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 | 2010-10-28 |