MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: NAIL LOCKING; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown expert retrograde/antegrade femoral nail (rafn) locking screw/unknown lot.Part and lot number are unknown; udi number is unknown.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.

Event Description

It was reported that on an unknown date, the patient underwent an antegrade intramedullary procedure for subtrochanteric fracture of the right femur, closed with an associated injury of severe right acetabulum fracture with femoral head protrusion and left sided pubic rami fractures with right femoral artery injury and traumatic brain injury.There was an infection but there was no delayed union/nonunion of fracture.Other complication includes extensive ho with a connection between the acetabulum and greater trochanter.A reoperation occurred including wound vac, fasciotomy, excision of right hip heterotopic ossification) and quadricepsplasty right thigh.Manipulation under anesthesia right (right) was performed.The patient outcome is unknown.No further information is available.This report is for an unknown expert retrograde/antegrade femoral nail (rafn) locking screw.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: NAIL LOCKING
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12385191
• MDR Text Key: 268714347
• Report Number: 2939274-2021-04994
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS; UNK - NAILS: FRN; UNK - SCREWS: RECON
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR