MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for FOREFOOT INTERNALBRACE IMPLANT WITH TWO 3 X 8 MM PEEK TENODESIS SCREWS & DISPOSA manufactured by Arthrex, Inc..
[178580081]
Pt in surgery for podiatry surgery. Surgeon using an arthrex forefoot internal brace implant system with two 3 x 8 mm peek tenodesis screws with disposable drivers. The inserter snapped off within the tenodesis screw that was inserted to secure the fiber tape in the metatarsal head. Efforts were made to remove the inserter from the area; however, they were unsuccessful. It was deemed that more damage would be done to the pt by trying to take this out versus leaving it in, so the inserter was left within the tenodesis screw. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092864 |
| MDR Report Key | 9686768 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-04 |
| Date Added to Maude | 2020-02-10 |
| 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 | FOREFOOT INTERNALBRACE IMPLANT WITH TWO 3 X 8 MM PEEK TENODESIS SCREWS & DISPOSA |
| Generic Name | SCREW, FIXATION, BONE |
| Product Code | HWC |
| Date Received | 2020-02-07 |
| Lot Number | 10499699 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Brand Name | INSTRUMENT, SCREWDRIVER, MANUAL, SURGICAL USE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL USE |
| Product Code | MDM |
| Date Received | 2020-02-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |