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

Model Number	94-1300-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint history for the thorecon product line shows that there have been no prior complaints regarding the screw breaking.This results in a complaint rate of (b)(4) ((b)(4) complaint per (b)(4) devices sold in the past 24 months from the date of this complaint from 07jun2019 to 07jun2021).It should be noted that there was no patient injury in this instance.The returned screw was recently received, and an evaluation will be conducted.A closure report will be submitted once investigation is complete.
Event or Problem Description
A distributor associate reported that the thorecon screw broke when placing into the bone during a sternotomy procedure at aurora bay care hospital in green bay, wi.The surgeon stated that the screw felt different.The surgeon was able to get it out of the patient by using another instrument to get the screw out.The screw broke into two pieces; one piece was in the patient but was removed.It was reported that there was no patient injury.
Additional Manufacturer Narrative
The broken screw was returned and fracture and material analysis via scanning electron microscopy (sem) analysis was performed.The results concluded that the screw is suspected to have fractured due to torsional overload.Per the warnings in the instructions for use, intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws.The analysis also found no material defects observed on the sample.The contract manufacturer of this device also performed an investigation on the returned screw and also concluded that there were no material defects.They were also able to confirm that the dimensions of the screw were within tolerance, and the specifications of the raw material used to make the screw was within the tolerance requirements for inspection.The device history records were reviewed as well and did not indicate any manufacturing related issues that could be correlated with this complaint.Furthermore, the customer that reported this complaint also reported that other units from the same lot have been used without issue.As described previously, there have been no prior complaints of the screw breaking when placing it into the bone, resulting in a complaint rate of 0.02% (1 complaint per (b)(4) devices sold in the past 24 months from the date of this complaint from 07jun2019 to 07jun2021).Therefore, given that this is an isolated incident, and that the results of the investigation of the returned screw did not indicate any material defects and confirmed the dimensions met all specifications, it is likely that the screw broke due to excessive torque as concluded by the sem analysis.No further action is required and a&e medical will continue to monitor for similar concerns.
Event or Problem Description
A distributor associate reported that the thorecon screw broke when placing into the bone during a sternotomy procedure at aurora bay care hospital in green bay, wi.The surgeon stated that the screw felt different.The surgeon was able to get it out of the patient by using another instrument to get the screw out.The screw broke into two pieces; one piece was in the patient but was removed.It was reported that there was no patient injury.

• 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
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: vashina shukla ; 5206 asbury road; farmingdale, NJ 07727 ; 7329387337
• MDR Report Key: 12124910
• Report Number: 2242056-2021-00005
• Device Sequence Number: 20037959
• Product Code: JDQ
• UDI-Device Identifier: 10841291105640
• UDI-Public: (01)10841291105640(17)221007(10)381206;(01)10841291105640(17)221007(10)381207
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 10/07/2022
• Device Model Number: 94-1300-04
• Device Lot Number: 381206 OR 381207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 01/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown