MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for ATLAS CABLE SYSTEM 826-211 manufactured by Warsaw Orthopedics.
[41782415]
(b)(6). (b)(4). The product is not returned to manufacturer for evaluation therefore cause of event cannot be determined
Patient Sequence No: 1, Text Type: N, H10
[41782416]
Pre-operative diagnosis: broken rod it was reported that on (b)(6) 2016, intra-op, the doctor was using a double cable. As he was treading the device through the bone he pulled on the smooth bit and it broke off at the join where the smooth and braided bit meet. Then, they opened a single one to use and replace the broken bit. No fragments of the product remained inside the patient. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[48103144]
Product analysis :visual review of cable confirms breakage. Optical and microscopic examination of the weld and cable area immediately to the fracture did not identify material deformation or crack. Visual and optical examination of the cable broken-off portion of the cable lead identified significant and multiple bends, these bending stresses may have generated sub-critical cracking and contributed to subsequent failure. 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
[100821220]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2016-00885 |
| MDR Report Key | 5540616 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-03-05 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2011-02-18 |
| Date Added to Maude | 2016-04-01 |
| 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 | 2016-04-01 |
| Returned To Mfg | 2016-04-21 |
| Model Number | NA |
| Catalog Number | 826-211 |
| Lot Number | 0139048W |
| Device Expiration Date | 2019-02-10 |
| 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 | 2016-04-01 |