MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for UNK - GUIDES/SLEEVES/AIMING: AIMING ARM manufactured by Wrights Lane Synthes Usa Products Llc.
[186109859]
This report is for an unknown aiming arm/ unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a synthes employee. 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. (b)(4). 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
[186109860]
It was reported that on an unknown date the patient had an unknown procedure using a trochanteric femoral nailing advanced (tfna) system. During the surgery, while installing the tfna and approaching the intramedullary (im) canal, it was realized that the canal was too tight distally. The canal was reamed after cabling the femur to reduce a section of the fracture. After reducing the fracture with the unknown cables, the surgeon began reaming for an unknown nail and installed the nail. Then the surgeon began the proximal locking with an unknown helical blade and everything was fine. However, when the surgeon began attempting to lock distally by drilling the hole, the surgeon heard the chattering of the bone and the drill would not advanced any further. The surgeon changed the drill and drilled again, the aiming arm and insertion handle to tfna were tight and attached properly with everything in the proper location. Finally, the surgeon then removed the aiming arm and insertion handle and attempted to freehand the distal locking screw when he heard a chattering. The surgeon stop drilling and could not drill for the distal locking hole and finished without the distal locking screw. Procedure and patient status were unknown. Concomitant devices: unknown reamer (part # unknown, lot # unknown, quantity 1), unknown cable (part # unknown, lot # unknown, quantity unknown), unknown tfna helical blade (part # unknown, lot # unknown, quantity 1). This report is for one unknown aiming arm. This is report 3 of 6 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01372 |
| MDR Report Key | 9855940 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - GUIDES/SLEEVES/AIMING: AIMING ARM |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-19 |
| 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 | 1. Required No Informationntervention | 2020-03-19 |