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

Model Number	94-1700-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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 cable breaking during surgery.Furthermore, no patient injury was reported, and the surgeon was able to place a new implant.The dhr for the reported lot was reviewed and it does not indicate there were any issues with the output of production associated with this complaint.The returned device was recently received, and an evaluation will be conducted.A closure report will be submitted once investigation is complete.
Event or Problem Description
The cable of the thorecon ladder cable plate kit reportedly broke during surgery.A new implant was successfully placed resulting in an 8 minute delay to the procedure.It was reported the surgical technique guide was not used during the procedure.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot was reviewed and it did not indicate there were any issues with the output of production associated with this complaint.Tensile testing on the cable was performed during in-process inspection for this lot as documented in the dhr.The device was returned to a&e medical and investigated.The investigation found that the cable ends did not break as a result of the tensioning process of the cable (they did not break clean through during the surgery); they were cut and the other ends with the leader portion of the cable were discarded before the customer returned the medical device.We know this because the portion with the leader was not returned, and the cable did not show any signs of elongation, which would have to occur with the way the strands are woven.Furthermore, the two portions of the cable were within 0.25" of each other in length, and the probability of both portions breaking at the same time could not occur with how the device is tensioned.It was observed that the portions of the cable that are broken are barbed and unelongated.Therefore, it is likely that that the cable was damaged by the user due to contact with a sharp blade edge or something similar during the procedure.Given that the investigation did not indicate the device was defective, and the low occurrence rate for this event, no further action is required at this time and a&e will continue to monitor for similar concerns.
Event or Problem Description
The cable of the thorecon ladder cable plate kit reportedly broke during surgery.A new implant was successfully placed resulting in an 8 minute delay to the procedure.It was reported that the surgical technique guide was not used during the procedure.

• 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 COPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: vashina shukla ; 5206 asbury road; farmingdale,, NJ 07727 ; 7329387337
• MDR Report Key: 12744772
• Report Number: 2242056-2021-00007
• Device Sequence Number: 6268916
• Product Code: JDQ
• UDI-Device Identifier: 10841291105688
• UDI-Public: (01)10841291105688(17)221016(10)377939
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/23/2022

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: 10/15/2022
• Device Model Number: 94-1700-10
• Device Lot Number: 377939
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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