MAUDE Adverse Event Report: A&E MEDICAL CORPORATION THORECON® RIGID FIXATION SYSTEM; STERNAL FIXATION SYSTEM

Model Number	94-1300-04-S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While using the thorecon® plating system a surgeon tried to tighten down a set screw in order to secure the cable.The screw did not tighten as designed, but instead spun freely in the plate.The surgeon cut the cable and used a sternum wire over the plate for extra stability.No patient harm was indicated.The exact date of the procedure is unknown; however, it was indicated that it occurred in the first week of august.The device was implanted into the patient thus no product was returned for evaluation.After investigating the complaint and examining product from stock, it was concluded product was within specification.The spinning screw could be replicated by over tightening of the screw or manipulation of the crimp or plate.Based on the results of the investigation, most likely cause of the issue was use error associated with plate manipulation/bending resulting in deformation of the screw hole or seating and unseating of the screw multiple times damaging the internal geometry of the plate.Both of these potential causes of the complaint appear to be associated with over tightening or excessive force applied to the set screw.The instructions for use do caution against bending or modifying the plates as this can contribute to malfunctions.Relevant testing is on file and demonstrates that the thorecon® plate is suitably functional as a standalone plate without the cable component.A cable-less thorecon® plate is effective in achieving sternal closure.
Event or Problem Description
While using the thorecon® plating system a surgeon tried to tighten down a set screw in order to secure the cable.The screw did not tighten as designed, but instead spun freely in the plate.The surgeon proceeded to use a sternum wire over the plate as he or she believed it was necessary for extra stability.No device was not returned for investigation.No patient harm was indicated.The exact date of the procedure is unknown, however, it was indicated that it occurred in the first week of august.

• Brand Name: THORECON® RIGID FIXATION SYSTEM
• Common Device Name: STERNAL FIXATION SYSTEM
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 9098623
• Report Number: 2242056-2019-00006
• Device Sequence Number: 2700106
• Product Code: JDQ
• UDI-Device Identifier: 10841291105657
• UDI-Public: 10841291105657
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: 94-1300-04-S
• Device Catalogue Number: 94-1300-04-S
• Device Lot Number: 327703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention