MAUDE Adverse Event Report: PSS SYSTEM; SCREWDRIVER

Model Number	00-9002
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SCREWDRIVER
• MDR Report Key: 12636264
• Report Number: 3005739886-2021-00052
• Device Sequence Number: 1140504
• Product Code: HXX
• UDI-Device Identifier: 00840019925594
• UDI-Public: 00840019925594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention