MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for ARTHREX SCORPION MULTIFIRE AR-13995N manufactured by Arthrex, Inc..
[178349743]
Scorpion multifire arthrex product # (b)(4), lot # 10516557 while using this product the tip broke off in the patient. X-ray was used to find the tip and remove it from the patient. No injury noted. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092821 |
| MDR Report Key | 9681608 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Date Added to Maude | 2020-02-07 |
| 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 | ARTHREX SCORPION MULTIFIRE AR-13995N |
| Generic Name | INSTRUMENT, MANUAL, SURIGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-02-06 |
| Model Number | AR-13995N |
| Lot Number | 10516557 |
| 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 | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |