MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-26 for META-NAIL TIBIAL 8.5MM X 32CM 71655032 OR71655032 manufactured by Smith & Nephew, Inc..
[185487227]
It was reported that during surgery the tibia nail placement was performed retrogradely with an entry point in the calcaneus, sure shot technique was performed for placement of two proximal locking screws, and placement of two distal screws with directional arm at the calcaneus level. The specialist decided to place the tibia nail of 8. 5 320 mm because when performing the corrective osteotomies in the tibia at the distal and diaphyseal level, the hind foot nail did not cover the length required for fixation. The surgery was finish using an alternate technique. No adverse events or health problems have occurred to the patient. There was a delay below 30 minutes and no backup device was necessary to finish the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01031 |
| MDR Report Key | 9886436 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2020-03-26 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | META-NAIL TIBIAL 8.5MM X 32CM |
| Generic Name | NAIL, FIXATION, BONE |
| Product Code | JDS |
| Date Received | 2020-03-26 |
| Model Number | 71655032 |
| Catalog Number | OR71655032 |
| Lot Number | 17LM04861 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |