MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for ARTHREX SHAVER-CURVED TORPEDO AR-8400CTD manufactured by Arthrex, Inc..
[176606822]
Shaver arthrex 1? Inch piece broke in surgical site during procedure, piece retrieved, x-ray negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092494 |
| MDR Report Key | 9631955 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Added to Maude | 2020-01-27 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHREX SHAVER-CURVED TORPEDO |
| Generic Name | BLADE, SAW GENERAL AND PLASTIC SURGERY, SURGICAL |
| Product Code | GFA |
| Date Received | 2020-01-24 |
| Catalog Number | AR-8400CTD |
| Lot Number | 10268875 |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2020-01-24 |