MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-23 for SCORPION-MULTIFIRE NEEDLE AR-13995N 149850 manufactured by Arthrex, Inc..
[176420592]
During the right shoulder arthroscopic rotator cuff repair, the tip of the scorpion needle broke off. Removing the tip might cause more damage to the rotator cuff tendon so it was safer to leave it than remove it. X-ray confirmed the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092464 |
| MDR Report Key | 9627103 |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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-MULTIFIRE NEEDLE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-23 |
| Model Number | AR-13995N |
| Catalog Number | 149850 |
| Lot Number | 10404639 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |