MAUDE Adverse Event Report: A&E MEDICAL CORPORATION THORECON (R) RIGID FIXATION SYSTEM; STERNAL PLATE ASSEMBLY

Model Number	94-1200-08
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A&e medical corporation is the legal manufacturer for device 94-1200-08.Rti surgical located at (b)(4) is the contract manufacturer for this device.Upon the request from a&e medical corporation, rti surgical has evaluated the returned device and provided a&e medical corporation with the investigation summary report.[(b)(4)].
Event or Problem Description
Needle on a thorecon plate broke off while being passed around the sternum.No broken fragments were reported.A surgical delay of approximately (3) minutes was incurred.A double suture wire was used in lieu of the plate system.There was no injury to patient.

• Brand Name: THORECON (R) RIGID FIXATION SYSTEM
• Common Device Name: STERNAL PLATE ASSEMBLY
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury rd.; farmingdale NJ 07727
• MDR Report Key: 8495096
• Report Number: 2242056-2019-00001
• Device Sequence Number: 1871526
• Product Code: JDQ
• UDI-Device Identifier: 10841291105633
• UDI-Public: 10841291105633
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: 08/23/2020
• Device Model Number: 94-1200-08
• Device Catalogue Number: 94-1200-08
• Device Lot Number: 323481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/09/2019
• 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