MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tfna nail/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. 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.

Event Description

It was reported that on an unknown date, the patient had a subtrochanteric nonunion. An exchange was made with grafting after compressing and plating. Radiographic and clinic progress was looking great until she rebroke. The proximal screw, nail, and plate removal were performed without event. During the distal nail removal downward tapping, vice grip back-slapping, distal finger extraction, thin osteotomes, and breaking the hip revision vice-grip slap hammer were attempted. A clamshell osteotomy was attempted and when it nearly spanned, the femur the nail gave. The osteotomy proceeded with a sequential cable fixation to close the osteotomy. The lateral periprosthetic femur plate was used to neutralize the femur and reattach the trochanter. The proximal trochanter screw was disengaged which allowed making a proximal neck cut, the head and ligamentum teres were removed and the head was sized. The patient outcome was unknown. This report is for one (1) unknown trochanteric fixation nail advanced (tfna) nail. This is report 1 of 5 for (b)(4).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12738627
• MDR Text Key: 279612292
• Report Number: 2939274-2021-06441
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/02/2021 Patient Sequence Number: 1

Treatment

UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - PLATES: TRAUMA; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: TRAUMA