MAUDE Adverse Event Report: PSS SYSTEM; SCREWDRIVER

Model Number 00-9002

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Patient information - unknown.Occupation - other; office manager.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Event Description

It was reported that a procedure was performed on (b)(6) 2021 utilizing the s-lok posterior lumbar pedicle screw system.When attempting to insert a 8.5mm x 50mm s-lok polyaxial screw the tip of the polyaxial screwdriver locking (00-9002) broke off in the head of the screw.The screw was removed and replaced and the procedure was completed without further issue.

Event Description

It was reported that a revision procedure to remove and replace another company's product was performed on (b)(6), 2021, utilizing the s-lok posterior lumbar pedicle screw system.During the procedure all the pedicle screws had been placed, tabs broken off and locking caps were being inserted and final tightened.When attempting to final tighten the last lock screw it cross threaded and stripped.The pedicle screw then had to be removed due to damage to the tulip threads and upon attempted removal, the tip of the polyaxial screwdriver locking (00-9002) broke off.The head of the screw was then cut off and the screw shank was removed successfully.Another screw was placed without further issue utilizing the second driver readily available in the set.There was a delay of twenty (20) minutes because of the broken driver.No patient injury was reported.

Manufacturer Narrative

H3 device evaluation - both the fractured screwdriver and screw containing the broken screwdriver tip were returned.However, contrary to the information provided, the head of the screw was not cut off.Visibly, the fracture region of the screwdriver shows signs of torsional sheer.Given the age of the device, 10+ years, this particular driver greatly exceeded its expected service life cycle.For this reason, no corrective action is recommended at this time.Review of device history records found (b)(4) pieces of lot 1988ti were released for distribution on 12/20/2010 with no deviation or anomalies.Complaint history review did not reveal a trend for reports of this nature for the reported part number.

• Brand Name: PSS SYSTEM
• Type of Device: SCREWDRIVER
• MDR Report Key: 12636264
• MDR Text Key: 276557151
• Report Number: 3005739886-2021-00052
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019925594
• UDI-Public: 00840019925594
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-9002
• Device Catalogue Number: 00-9002
• Device Lot Number: 1988TI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention