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

Model Number	400-689
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pioneer surgical technology has tried unsuccessfully to get more information from the (b)(6) hospital that this took place in.This incident is one of three patient incidents that were reported at the same time for the same device part and lot number combination.None of these incidents have been able to be confirmed at this time.We will continue to request more information.The dhr was reviewed along with sterilization records and all conform to specifications.Not returned.
Event or Problem Description
It was reported from the country of (b)(6) that a patient had experienced infection after a surgery using pioneer surgical technology sternal cable system.No more information has been made available.

• Brand Name: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) STERNAL CABLE SYSTEM
• Common Device Name: STERNAL CABLE SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6397362
• Report Number: 1833824-2017-00007
• Device Sequence Number: 13615613
• Product Code: JDQ
• UDI-Device Identifier: 00846468040895
• UDI-Public: (01)00846468040895(17)200127(10)203638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K935481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: No Information
• Device Expiration Date: 01/27/2020
• Device Model Number: 400-689
• Device Catalogue Number: SAME
• Device Lot Number: 203638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/10/2017
• Patient Sequence Number: 1