MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-08 for ARTHREX SUREFIRE SCORPION AR13991N manufactured by Arthrex.
[3424718]
The pt had a return rotator cuff. The pt was given an arthroscopic repair using arthrex instruments/the scorpion was used. This device had a disposable needle insert. During the repair, one of the inserts broke off of the scorpion devices. The surgeon was aware. The surgeon is bringing the pt in for x-ray and assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030135 |
| MDR Report Key | 3111730 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-04-29 |
| Date of Event | 2013-04-01 |
| Date Added to Maude | 2013-05-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX SUREFIRE SCORPION |
| Generic Name | SCORPION |
| Product Code | MFJ |
| Date Received | 2013-05-08 |
| Model Number | AR13991N |
| Catalog Number | AR13991N |
| Lot Number | 961926T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX |
| Manufacturer Address | 1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |