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

Model Number 86-500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  malfunction  

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 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
• Type of Device: STERNAL PLATE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 6812833
• MDR Text Key: 83617967
• Report Number: 1833824-2017-00023
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 00846468049775
• UDI-Public: (01)00846468049775(17)210120(10)234985
• Combination Product (y/n): N
• PMA/PMN Number: K150581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1