MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2015-05-01 for SEGWAY ENDOSCOPIC SYSTEM 200-1003 UNK manufactured by Segway Orthopaedics, Inc..
[19070532]
The segway retrograde ligament knife blade broke right at the blade junction. The blade was used in a surgical procedure for plantar fasciotomy. The medical facility did not release the device for eval until months later. The broken piece of the device was retrieved and a new device from the same lot number 1061401 was used to compare and make sure all pieces were received. The surgeon reported that the pt who is the subject of this report had extremely hard fascia. The broken blade has been inspected. Test blades were also inspected. Conclusion to incident: since no other incidents have been reported and no deformities were visible to the blade it, has been concluded that this was an isolated incident and was likely due to the blade erroneously being pressed up against the calcaneus with force. The risk files were also reviewed and updated accordingly to consider and mitigate this risk.
Patient Sequence No: 1, Text Type: N, H10
[19093152]
This report is a follow up to a report submitted by (b)(6) on 06/17/2014. While using the segway retrograde ligament knife, the tip of the blade broke off inside the guide which was in the pts foot. Using a scope and fluoroscopy, it was determined that the piece was retrieved from the pt's foot. What was the original intended procedure? Right foot plantar fasciotomy. Device usage problem: device failed. (e. G. Broke, couldn't get it work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010054483-2014-00001 |
| MDR Report Key | 4746264 |
| Report Source | 06,07,08 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-26 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-23 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-06-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STUART SEYMOUR |
| Manufacturer Street | 5205 AVENIDA ENCINAS, SUITE C |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7609290313 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEGWAY ENDOSCOPIC SYSTEM |
| Generic Name | KNIFE, ORTHOPEDIC |
| Product Code | HTS |
| Date Received | 2015-05-01 |
| Returned To Mfg | 2014-09-15 |
| Model Number | 200-1003 |
| Catalog Number | UNK |
| Lot Number | 1061401 |
| ID Number | NA |
| Device Expiration Date | 2018-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEGWAY ORTHOPAEDICS, INC. |
| Manufacturer Address | 5205 AVENIDA ENCINAS, SUITE C CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-01 |