MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[34620201]
(b)(6). (b)(4). The product has not been returned yet. Hence , no conclusions can be drawn as yet.
Patient Sequence No: 1, Text Type: N, H10
[34620202]
It was reported that , intra-op, the cable broke at cable integral crimp interface. Reportedly, the cable was tensioned to approx. 15-20 lbs. At time of breakage, the product came in contact with the patient. No fragment of the broken cable remained inside the patient. No patient symptoms or complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[39941645]
Product analysis: visual review confirms cable breakage, with approximately ~80 mm of cable missing from the integral crimp assembly. Microscopic examination of the cable identifies bend in the cable with surface strand damage both above and below the breakage. 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. Conclusion: the above observations suggest 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
| Report Number | 1030489-2015-03511 |
| MDR Report Key | 5313142 |
| Date Received | 2015-12-21 |
| Date of Report | 2016-02-26 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2015-07-11 |
| Date Added to Maude | 2015-12-21 |
| 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 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| 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 | 2015-12-21 |
| Returned To Mfg | 2016-02-05 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | 0400387W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-12-21 |