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

Model Number 94-1300-04-S

Device Problem Insufficient Information (3190)

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

Event Date 08/01/2019

Event Type  malfunction  

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 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
• Type of Device: STERNAL FIXATION SYSTEM
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: peter browne ; 5206 asbury road; farmingdale, NJ 07727 ; 7329387337
• MDR Report Key: 9098623
• MDR Text Key: 189629133
• Report Number: 2242056-2019-00006
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10841291105657
• UDI-Public: 10841291105657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention