MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 830-043

Device Problem Component Missing (2306)

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

Event Date 02/12/2020

Event Type  malfunction  

Event Description

The patient had to be scheduled for an additional unplanned procedure directly following the scheduled procedure in order to remove a countable item.The patient was undergoing a posterior spinal fusion procedure when the scrub tech notified the attending surgeon that she did not receive back a "pin" from the field.Initially, a search of the incision site, surrounding tissue, and surrounding sterile field was made.The floor and back table were also searched.Since fluoroscopy was already being used during the case, fluoroscopy was used to determine if the location of the missing pin was in or around the patient.Under fluoroscopy imaging, it was seen that the pin was in the patient, that it had been pushed through the back and into the chest cavity.Attempts by the ortho surgical team were made to pull and retrieve the pin but they were unsuccessful.General surgery was consulted to remove the pin.Ortho and general surgery came up with the plan that it was best for the ortho team to go ahead and finish their procedure and close, then afterwards, the patient would be repositioned supine, reintubated with a double lumen tube, then laterally positioned, and general surgery would perform a thoracoscopic procedure to attempt to removed the pin.Incorrect counts were charted for the closing counts of the ortho procedure.General surgery obtained consent and performed a thoracoscopic removal of foreign object.The patient was also unplanned transferred to the picu.The error was detected as it happened and the appropriate people were informed.Determine what exactly in the process caused the pin to be accidentally pushed to the thoracic cavity.Create a process/system that prevents accidental pushing and loss of pins.

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 9910210
• MDR Text Key: 185943052
• Report Number: 9910210
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 830-043
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6205 DA