MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); PEDICLE SCREW SYSTEM

Model Number 05-PA-65-45

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

The screw was left in the patient along with the tip of the driver and the surgeon has no plans to revise at this time.There was no reported injury caused to the patient due to this issue.A device history record review could not be completed since the device remains in the patient and the lot number is not known.The final driver that is associated with this occurence was reported under mdr 1833824-2018-00039.

Event Description

After the surgeon final locked the set screws, it was noticed that a screw had disassociated.When the surgeon tried to remove the set screw to retrieve the pedicle screw the final driver tip broke off and implanted in the screw.The surgeon decided to leave the tip of the driver and the disassociated screw in the patient.

• Brand Name: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 8134458
• MDR Text Key: 129467010
• Report Number: 1833824-2018-00038
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-65-45
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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