MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-01-09 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.
[64125986]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[64125987]
It was reported that on 22 nov 2016, the patient got the surgery due to fracture of hip joint prosthesis. Intra-op, it was found that the product broke two times in normal torque range. The physician had to replace a new one to complete the surgery successfully. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[71338319]
Product analysis: visual review confirms cable breakage. Microscopic examination of the cable identifies multiple bends in the cable with strand damage away from the fracture area. All strand fracture surfaces appear to contain varying degrees of damage and/or mechanical smearing. Microscopic examination of multiple individual cable strand fracture surfaces reveal fairly flat fracture surfaces, with a surface angulation consistent with shear overload. Additionally, several other strands appear to show necking, consistent with tensile overload. This suggests initial failure due to shear, thus weakening the cable, placing increasing tensile stress on the remaining intact strands until ultimate tensile failure. The above observations suggests initial failure due to shear, thus weakening the cable, placing increasing tensile stress on the remaining intact strands until ultimate tensile failure.
Patient Sequence No: 1, Text Type: N, H10
[100816339]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-00066 |
| MDR Report Key | 6232244 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-09 |
| Date of Report | 2017-03-06 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 2016-02-09 |
| Date Added to Maude | 2017-01-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATLAS CABLE SYSTEM |
| Generic Name | CABLE |
| Product Code | ISN |
| Date Received | 2017-01-09 |
| Returned To Mfg | 2017-01-18 |
| Model Number | NA |
| Catalog Number | 826-213 |
| Lot Number | 0456161W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-09 |