MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE 04.037.259S manufactured by Wrights Lane Synthes Usa Products Llc.
[186140248]
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[186140249]
It was reported that on (b)(6) 2020, the patient underwent revision surgery due to adverse events. On (b)(6) 2020, the patient presented to the surgeon with pain and was found to have a nonunion of the fracture site and mechanical fatigue of the locking screw and a titanium cannulated proximal femoral nailing system (tfna) long nail. The tfna helical blade, nail, and the lateral segment of the locking screw were removed. No attempt was made to retrieve the medial segment of the locking screw. The non-union site was debrided and a cannulated trochanteric fixation nail, helical blade, and locking screw were inserted. The date of the original implant was on (b)(6) 2019, for a proximal femur fracture. The procedure outcome is unknown. There was a patient consequence. Concomitant device reported: 5. 0mm ti locking screw w/t25 stardrive 40mm f/im nail-ster (part # 04. 005. 530s, lot # h218356. Quantity 1), tfna fenestrated helical blade 100mm - sterile (part # 04. 038. 400s, lot # unknown. Quantity 1), this report is for one (1) 12mm/ 130 deg ti cann tfna 380mm/ left-sterile. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01593 |
| MDR Report Key | 9897969 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2016-10-28 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE |
| Generic Name | ROD,FIXATION,INTRAMEDULLARY |
| Product Code | HSB |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-20 |
| Model Number | 04.037.259S |
| Catalog Number | 04.037.259S |
| Lot Number | H218356 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |