MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STERNAL CABLE SYSTEM; BONE FIXATION CERCLAGE

Model Number	400-689
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for this complaint.Therefore, no device investigation could be done other than a review of the manufacturing records related to the part.According to the dhr, the product was manufactured to specifications.Repeated inquiries to gather more information about this case have not resulted in any additional information beyond what is listed in this report.
Event or Problem Description
On 8/25/2021 it was reported to pioneer surgical technology that "a patient, called in stating he has a broken wire in his chest.He found this out at a dr appt on (b)(6) 2021.Original date of surgery was (b)(6) 2019 at (b)(6).He has been told by his surgeon that he is going to have to have another surgery to replace the broken wire.".

• Brand Name: PIONEER SURGICAL TECHNOLOGY STERNAL CABLE SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• MDR Report Key: 12521248
• Report Number: 1833824-2021-00080
• Device Sequence Number: 4068166
• Product Code: JDQ
• UDI-Device Identifier: 00846468040895
• UDI-Public: (01)00846468040895(17)230531(10)316016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 05/31/2023
• Device Model Number: 400-689
• Device Lot Number: 316016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1