MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANT 62387001 manufactured by Wright Medical Technology Inc..
[116451897]
During osteotomy of left foot, the tips of two different rasps broke off into the bone. The surgeon was unable to remove and they were left in the foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078900 |
| MDR Report Key | 7757330 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-26 |
| Date Added to Maude | 2018-08-07 |
| 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 | 0 |
| Brand Name | SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANT |
| Generic Name | PROSTHESIS, TOE. CONSTRAINED, POLYMERIC |
| Product Code | KWH |
| Date Received | 2018-08-06 |
| Returned To Mfg | 2018-07-27 |
| Model Number | 62387001 |
| Lot Number | 33 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY INC. |
| Manufacturer Address | MEMPHIS TN US |
| Brand Name | SWANSON FLEX HINGE LATERAL TOE INSTRUMENT + IMPLANT |
| Generic Name | PROSTHESIS, TOE. CONSTRAINED, POLYMERIC |
| Product Code | KWH |
| Date Received | 2018-08-06 |
| Model Number | 1441712 |
| Lot Number | 33 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |