• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY SYNTHES, INC. DEPUY SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL EX AIMING ARM FOR EX-ALEFN ROD, FIXATION, INTRAMEDULARY AND ACCESSORIES Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEPUY SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL EX AIMING ARM FOR EX-ALEFN
Type of DeviceROD, FIXATION, INTRAMEDULARY AND ACCESSORIES
Manufacturer (Section D)
DEPUY SYNTHES, INC.
MDR Report Key8949723
MDR Text Key156321458
Report NumberMW5089465
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number03.010.227
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-