MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-30 for PELVIC C-CLAMP II 03.306.010 manufactured by Synthes Gmbh.
[3047200]
During an orif of the pelvis, the locking mechanism on the pelvic c-clamp jammed. The surgeon had to use a vice grip, mallet and bone tamp to be able to get the clamp apart and remove the clamp. The surgeon then used a second pelvic c-clamp and it also jammed. The surgeon again used the vice grip, mallet and bone tamp to remove the clamp. At this point the surgeon aborted the procedure and closed the patient. Revision surgery is scheduled for (b)(6) 2012. This is 1 of 2 reports for the same event.
Patient Sequence No: 1, Text Type: D, B5
[10340157]
Device was used for treatment. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. The manufacturing records were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
[10464078]
A manufacturing evaluation was conducted. The device shows marks of forcible and inadequate use; there are bent and damaged movable parts and visible hammering marks. The source of this damage cannot be determined. Due to the overall damage of the device, it cannot be verified to the post-op conditions. The device history record review shows that the device met the specifications at the time of manufacturing/distributing. A product development event evaluation was conducted. Reportedly, the surgeon uses the device for reduction and compression of sacroiliac fracture/dislocations. Jamming of the device could be caused by several factors: inappropriate use of the device, inappropriate technique, malfunction of components, inappropriate materials specified for the device, or design/tolerances for mating parts not appropriate. Based on the complaint description and subsequent information, it appears that the device is being used inappropriately. Per the technique guide, the device is intended to be used for emergent cases to stabilize unstable pelvic ring injuries. It is not intended to be a compression device. Reportedly during the procedure, enough energy was applied through the threaded tubes that the rails and upper arms bent (but not permanently, as the devices returned were not bent). This strongly suggests that an inappropriately high force was being applied to the instrumentation. If this force on the system is not relieved, it is difficult to release the locking mechanisms and buttons to remove the instrumentation. It was reported that the surgeon tried to relieve the force, but the threaded tubes were jammed, so this was not possible. Materials specified in the design can prevent (to some degree) galling or seizing. However, the materials are appropriate for the intended use of stabilizing pelvic ring injuries. All other aspects of the design appear to be fine. Besides the threaded tubes being jammed, all other components that are not damaged are working. The damage noted in the part evaluation is due to the reported hammering by the surgeon to unlock the system. Further investigation of the threads is suggested as machine lines are visibly present, which can also lead to galling and seizing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-01421 |
| MDR Report Key | 2852073 |
| Report Source | 05,07 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-03 |
| Date of Event | 2012-11-03 |
| Date Mfgr Received | 2012-11-03 |
| Date Added to Maude | 2012-11-30 |
| 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 | SARMA PIN |
| 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 | PELVIC C-CLAMP II |
| Generic Name | PELVIC C-CLAMP |
| Product Code | JEC |
| Date Received | 2012-11-30 |
| Returned To Mfg | 2012-11-13 |
| Catalog Number | 03.306.010 |
| Lot Number | 2471520 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2012-11-30 |