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 2020-03-27 for TFNA FENESTRATED HELICAL BLADE 100MM - STERILE 04.038.400S manufactured by Wrights Lane Synthes Usa Products Llc.
[185543402]
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[185543403]
It was reported that on (b)(6) 2020, during an orthopedic procedure, the surgeon experienced complications while using the proximal femoral nailing system (tfna) devices. Difficulties were encountered while using the stepped drill bit in preparation for the helical blade. After drilling, the surgeon proceeded to insert the helical blade component, which was difficult to insert. The surgeon proceeded to insert the distal locking screw and had complications with inserting it. Afterwards the surgeon noticed that an incorrect aiming arm (125 degree) was utilized. The tfna nail that was implanted was a 130 degree nail. It is unknown if there was a surgical delay. Patient status and surgical outcome were unknown. Concomitant device reported: tfna nail (part 04. 037. 142s, lot unknown, quantity 1), cannulated stepped drill bit (part 03. 037. 022, lot unknown, quantity 1), three-fluted drill bit (part 03. 010. 061, lot unknown, quantity 1), 5. 0mm ti locking screw w/t25 stardrive 42mm f/im nail-ster (part 04. 005. 532s, lot unknown, quantity 1), guides/sleeves/aiming: aiming arm (part number unknown, lot unknown, quantity 1). This report involves one tfna fenestrated helical blade 100mm? Sterile. This is report 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01553 |
| MDR Report Key | 9889260 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| 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 | TFNA FENESTRATED HELICAL BLADE 100MM - STERILE |
| Generic Name | ROD, FIXATION, INTRAMEDULLARY |
| Product Code | HSB |
| Date Received | 2020-03-27 |
| Model Number | 04.038.400S |
| Catalog Number | 04.038.400S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-27 |