MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for ARTHREX FLIPCUTTER 904290774 manufactured by Arhtrex, Inc..
[174481905]
Disposable item used called an arthrex flipcutter ii, short, during acl reconstruction surgery. During drilling metal tips of the device fractured. All pieces retrieved and an x-ray was taken before closure. Xray revealed no unanticipated radiopaque foreign bodies. Fda medwatch completed. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092050 |
| MDR Report Key | 9558460 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-12-26 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| 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 FLIPCUTTER |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-06 |
| Model Number | 904290774 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARHTREX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |