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

Model Number	400-425
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The maude report states that surgeon does not plan to revise, therefore, the broken fragment is unavailable for evaluation.A dhr review was conducted and confirmed that the device met all manufacturing specifications prior ro shipping from rti surgical.Additional information will be added to this report should it become available at a later date.
Event or Problem Description
During a routine maude search conducted by rti surgical, it was identified that an adverse event had taken place and the hospital filed a report with the fda.The hospital did not notify its distributor of this occurrence, therefore, rti surgical was also not notified.The event description provided in the maude states the following, "a (b)(6) male presented for a cabg x 5 due to outpatient workup demonstrating multivessel.Cad.The procedure was performed successfully and the surgeon began closure of the sternum.Upon implantation of cable into the sternum, a small portion of the sternal cable system broke off into the sternum.An intraoperative x-ray was taken that showed a radiopaque foreign body suggestive of the known fractured needle stuck in the pt's sternum.Upon assessment the surgeon determined that it would be more harmful to attempt to remove the metal than to keep it in place.The sternal edges were then closed using the cables and the wound was closed.The pt tolerated the procedure well and was admitted as per pre-hospital plan.No further issues due to broken item.Pt was able to be discharged home on 04/22 with plans to f/u as an outpatient.".

• Brand Name: PIONEER STERNAL CABLE SYSTEM
• Common Device Name: STERNAL FIXATION CABLE
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• MDR Report Key: 9817343
• Report Number: 1833824-2020-00018
• Device Sequence Number: 1299952
• Product Code: JDQ
• UDI-Device Identifier: 00846468040758
• UDI-Public: (01)00846468040758(17)230514(10)314215
• Combination Product (Y/N): N
• PMA/510(K) Number: K122293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 05/14/2023
• Device Model Number: 400-425
• Device Catalogue Number: N/A
• Device Lot Number: 314215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/11/2020
• 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: Other