MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-27 for 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT 900.726 manufactured by .
[18249829]
During a sacro iliac screw implant procedure the threaded guide wire calibration line was rubbed off after insertion by the wire driver making the measurement with a depth gauge unattainable. A replacement threaded guide wire was placed along side the inserted guidewire to obtain proper measurement for screw size. No delay to procedure no patient consequence reported.
Patient Sequence No: 1, Text Type: D, B5
[18326637]
This device was for treatment not diagnosis. Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-01217 |
| MDR Report Key | 2981419 |
| Report Source | 05,07 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-30 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-01-30 |
| Date Added to Maude | 2013-05-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RYAN MILLER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT |
| Generic Name | 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT |
| Product Code | DZK |
| Date Received | 2013-02-27 |
| Catalog Number | 900.726 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |