MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-04 for THREADED TUBE FOR PELVIC C-CLAMP II 03.306.008 manufactured by Synthes Gmbh.
[10498313]
Device used for treatment and not diagnosis. Based on the complaint description and further info provided by the sales consultant, extreme force applied through the threaded tubes caused the threads to jam/seize. Since the force in the system could not be relieved by unthreading the tubes, the locking buttons could not be released. Per the technique guide, the device is not intended to be used for compression. It is only intended to provide emergent and temporary stability to unstable pelvic ring fractures. The reported high loading applied to achieve compression caused the threads to seize. The device was not used as intended.
Patient Sequence No: 1, Text Type: N, H10
[21459405]
A report was received regarding the use of a pelvic c clamp 11 set. The surgeon clamped the device down and tightened the threaded tubes. When the surgeon tried to remove the clamp device, the threaded tube would not release. The tubes are stuck in the lower arms of the clamp device. No damage was apparent, visually. The surgeon pulled the pins and struck the top ratcheting in order to release it. The procedure was delayed by approximately 10 minutes. Reportedly, the procedure was not impacted in any other way. This is report #2 of 9 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[21501900]
Device was used for treatment. Investigation could not be completed, no conclusion could be drawn as no device was returned. A review of the device history record has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-01438 |
| MDR Report Key | 2855782 |
| Report Source | 05,07 |
| Date Received | 2012-12-04 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-11-06 |
| Date Mfgr Received | 2012-12-04 |
| Date Added to Maude | 2013-03-11 |
| 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 | DENISE BURKE |
| 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 | THREADED TUBE FOR PELVIC C-CLAMP II |
| Generic Name | THREADED TUBE |
| Product Code | JEC |
| Date Received | 2012-12-04 |
| Catalog Number | 03.306.008 |
| Lot Number | 2752754 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-12-04 |