MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for SCORPION NEEDLE AR-16991N manufactured by Arthrex, Inc..
[98689890]
Patient Sequence No: 1, Text Type: N, H10
[98689911]
Doctor was performing a hip arthroscopy on patient. As he inserted the arthrex scorpion needle, he noted that the tip had broken off of the needle. Needle removed, x-rays obtained with c-arm. Needle tip not visualized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7230381 |
| MDR Report Key | 7230381 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-16 |
| Report Date | 2018-01-18 |
| Date Reported to FDA | 2018-01-18 |
| Date Reported to Mfgr | 2018-01-18 |
| Date Added to Maude | 2018-01-31 |
| 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 | SCORPION NEEDLE |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | PBF |
| Date Received | 2018-01-31 |
| Catalog Number | AR-16991N |
| Lot Number | 10073092 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-31 |