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

Model Number	94-1400-04
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physician has used other thorecon product without issue.Unclear why this plate did not accept screws.No product returned for evaluation.No other complaints similar to this complaint.No indication of root cause in device history record.Considered an isolated event of undetermined cause.
Event or Problem Description
During sternal closure post open heart surgery, the box plate fixation device would not accept the screws to secure device.A ladder plate was used to complete the procedure.
Event or Problem Description
During sternal closure post open heart surgery, the box plate fixation device would not accept the screws to secure device.A ladder plate was used to complete the procedure.
Additional Manufacturer Narrative
Customer did not return device for evaluation.User was unable to provide additional information on reported failure of one screw that would not seat properly.No other reported issues with this product at the user site and no other reported issues of screws not seating in this lot of product.At this point in time, the event appears to be isolated and root cause is undetermined.

• Brand Name: THORECON RIGID FIXATION SYSTEM
• Common Device Name: STERNAL FIXATION SYSTEM
• Manufacturer (Section D): A&E MEDICAL; 5206 asbury rd; po box 758; farmingdale NJ 07727
• MDR Report Key: 10379193
• Report Number: 2242056-2020-00004
• Device Sequence Number: 11553019
• Product Code: JDQ
• UDI-Device Identifier: 10841291105664
• UDI-Public: (01)10841291105664(10)358407(17)2204022
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: 94-1400-04
• Device Lot Number: 358407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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
• Patient Age: 69 YR
• Patient Weight: 118