MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for SUREFIRE SCORPION NEEDLE AR-1399IN manufactured by Arthrex, Inc..
[180749382]
During surgery a surefire scorpion (arthrex) needle broke and the small portion which broke off could not be found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744200 |
| MDR Report Key | 9744200 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-07 |
| Date Facility Aware | 2020-02-10 |
| Report Date | 2020-02-10 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREFIRE SCORPION NEEDLE |
| Generic Name | SCORPION NEEDLE |
| Product Code | MDM |
| Date Received | 2020-02-11 |
| Model Number | AR-1399IN |
| Catalog Number | AR-1399IN |
| Lot Number | 10438073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |