MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for RIVAL BITE SYSTEM 001-A-1102P manufactured by Orthofix Srl.
[115062798]
Information provided states that during a distal bunionectomy the drill bits used would not go through the bone. One of the guide wires used in the case broke and was left in the patient's right metatarsal. The surgery was completed using a different product. No additional surgery required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183449-2018-00021 |
| MDR Report Key | 7720841 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-06-22 |
| Date Facility Aware | 2018-03-19 |
| Report Date | 2018-07-25 |
| Date Reported to Mfgr | 2018-07-25 |
| Date Added to Maude | 2018-07-25 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Brand Name | RIVAL BITE SYSTEM |
| Generic Name | GUIDE WIRE |
| Product Code | PBF |
| Date Received | 2018-07-25 |
| Model Number | 001-A-1102P |
| Lot Number | B1204948 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI 9 BUSSOLENGO, VERONA 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-25 |