MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC. TRITIUM STERNAL CABLE PLATE SYSTEM; PLATE, FIXATION, BONE

Model Number 86-400

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Event Description

While implanting the tritium sternal cable plate system, the cable broke off the plate.It had to be removed and a different plating system was used.There was no harm to the patient.

• Brand Name: TRITIUM STERNAL CABLE PLATE SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC.; 375 river park circle; marquette MI 49855
• MDR Report Key: 7486535
• MDR Text Key: 107352661
• Report Number: 7486535
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 86-400
• Device Catalogue Number: 86-400
• Device Lot Number: 292131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 107