MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for YWIRE YWIRE 110MM FC 110-22-B-2 manufactured by Safewire Llc.
[40260008]
Safewire, llc assets have been sold to a large medical device manufacturer. Their request is for all device / patient complaints to have a mdr completed. According to safewire procedures this complaint didn't warrant a mdr to be completed as it didn't impact the patient by surgical intervention, death or serious injury. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[40260009]
Upon the conclusion of a mis procedure it was determine that a ywire tip had broken. It was not determine at what point during surgery the wire broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008595221-2015-00002 |
| MDR Report Key | 5490083 |
| Date Received | 2016-03-09 |
| Date of Report | 2015-11-23 |
| Date of Event | 2012-11-12 |
| Date Facility Aware | 2012-11-12 |
| Report Date | 2012-11-12 |
| Date Reported to Mfgr | 2012-11-12 |
| Date Mfgr Received | 2012-11-12 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2016-03-09 |
| 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 | MR. STEPHEN INGLESE |
| Manufacturer Street | 8963 STIRLING RD SUITE 7 |
| Manufacturer City | COOPER CITY FL 33328 |
| Manufacturer Country | US |
| Manufacturer Postal | 33328 |
| Manufacturer Phone | 8002869155 |
| Manufacturer G1 | SAFEWIRE LLC |
| Manufacturer Street | 8963 STIRILING RD SUITE 7 |
| Manufacturer City | COOPER CITY FL 33328 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | YWIRE |
| Generic Name | YWIRE |
| Product Code | HXI |
| Date Received | 2016-03-09 |
| Model Number | YWIRE 110MM |
| Catalog Number | FC 110-22-B-2 |
| Lot Number | 24590,26171,24589 |
| Device Expiration Date | 2013-11-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAFEWIRE LLC |
| Manufacturer Address | 8963 STIRILING RD SUITE 7 COOPER CITY FL 33328 US 33328 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-09 |