MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY TRITIUM PLATE SYSTEM STERNAL PLATE

Model Number	86-500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a planned search of the fda maude database the report of this occurrence was discovered (b)(4).It is unknown as to who reported it or any of the details around this report.The dhr was reviewed for this device lot and it was found to be manufactured to specifications.This is the first reported type of occurrence for this part and lot number.
Event or Problem Description
During a sternum closure the surgeon broke three sternal plates while attempting to crimp the cable to the plates.According to the report there was no adverse event caused by this occurrence.

• Brand Name: PIONEER SURGICAL TECHNOLOGY TRITIUM PLATE SYSTEM STERNAL PLATE
• Common Device Name: STERNAL PLATE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6812833
• Report Number: 1833824-2017-00023
• Device Sequence Number: 1760962
• Product Code: JDQ
• UDI-Device Identifier: 00846468049775
• UDI-Public: (01)00846468049775(17)210120(10)234985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: Physician
• Device Expiration Date: 01/20/2021
• Device Model Number: 86-500
• Device Catalogue Number: SAME
• Device Lot Number: 234985
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1