MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for KIT INVISIKNOT ANKLE NON-FRACTURE 72204833 manufactured by Smith & Nephew, Inc..
[104416201]
Patient Sequence No: 1, Text Type: N, H10
[104416202]
It was reported that the doctor used the invisiknot non-fracture implant. When he tightened the invisiknot, the small medial button broke the cortex of the bone and the hole was compromised. We had to open another invisiknot and re-drill a new hole in the bone. This time it worked well. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2018-00398 |
| MDR Report Key | 7394192 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2018-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KIT INVISIKNOT ANKLE NON-FRACTURE |
| Generic Name | WASHER, BOLT NUT |
| Product Code | HTN |
| Date Received | 2018-04-03 |
| Catalog Number | 72204833 |
| Lot Number | 50661708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-03 |