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 2018-08-30 for ATLAS CABLE SYSTEM 826-213 manufactured by Warsaw Orthopedics.
[118743285]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118743286]
Pre-op diagnosis :humerus patellar fracture procedure: fracture it was reported that the cable broke intra-operatively. Patient was involved in the event but no patient complications or symptoms occurred.
Patient Sequence No: 1, Text Type: D, B5
[125501447]
Product analysis: the cable has been returned in two sections. A visual review of the two severed ends indicates the two pieces do not match. As one end appears to be a clean cut and the other end appears to have been frayed. A microscopic review of the individual cables shows that the angles are similar and there does not appear to be necking that is associated with linear force. There is also damage to the eyelet noted. It appears the cable may have been cut. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2018-01180 |
| MDR Report Key | 7831744 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-08-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| 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 | 2018-08-30 |
| Returned To Mfg | 2018-10-10 |
| Model Number | NA |
| Catalog Number | 826-213 |
| Lot Number | 0603584W |
| 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 | 2018-08-30 |