MAUDE Adverse Event Report: DEPUY SYNTHES, INC. DEPUY SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL EX AIMING ARM FOR EX-ALEFN; ROD, FIXATION, INTRAMEDULARY AND ACCESSORIES

Lot Number 03.010.227

Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2019

Event Type  malfunction  

Event Description

Aiming arm malfunctioned on adolescent lateral entry femoral nail.One of the locking mechanisms for the recon screws popped off of the arm when the surgeon was inserting the femoral nail into the pt.This did not negatively effect the outcome of the surgery in anyway nor hinder the surgeon to achieve the end goal.Fda safety report id# (b)(4).

• Brand Name: DEPUY SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL EX AIMING ARM FOR EX-ALEFN
• Type of Device: ROD, FIXATION, INTRAMEDULARY AND ACCESSORIES
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 8949723
• MDR Text Key: 156321458
• Report Number: MW5089465
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 03.010.227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR