MAUDE Adverse Event Report: PRECISION SPINE, INC. SURELOK MIS 3L; ROD INSERTER

Model Number	63-SP-9005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Device availability - information received indicates that the device is available for evaluation but has not yet been received by the manufacturer.Occupation - other: sales representative.Device evaluation - information received indicates that the device is available for evaluation but has not yet been received by the manufacturer.Upon receipt and completion of investigation, a follow-up medwatch report will be submitted.
Event or Problem Description
It was reported that a one-level procedure was performed on (b)(6) 2021, utilizing the surelok mis 3l percutaneous screw system.When the scrub tech tried to tighten the rod onto the inserter on the back table, the tip of the inserter broke off.Another inserter was readily availabe to successfully complete the procedure with no delay or issue to the patient.
Additional Manufacturer Narrative
H3 device evaluation - the inserter was returned for evaluation without the distal fractured tip.The laser markings are crisp and legible and the gold knob freely turns, driving the center shaft in and out.A 18 in-lbs torque limiting driver is supplied w/ the 3l mis system to tighten the rod implant to the inserter.This is illustrated in the surgical procedure for the system.In this instance, the torque limit driver was not used.Due to this, it is likely possible that an excessive torque was applied to the inserter.Review of device history records found that twenty-six (26) pieces of lot 00116pt-r were release for distribution on (b)(6) 2019 with no deviation or anomalies.No corrective action is recommended at this time due to the likelihood the failure can be attributed to an excessive load (torque) applied to the instrument.
Event or Problem Description
It was reported that a one-level procedure was performed on (b)(6) 2021, utilizing the surelok mis 3l percutaneous screw system.When the scrub tech tried to tighten the rod onto the inserter on the back table, the tip of the inserter broke off.Another inserter was readily availabe to successfully complete the procedure with no delay or issue to the patient.

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11649736
• Report Number: 3005739886-2021-00020
• Device Sequence Number: 3549988
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 63-SP-9005
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 00116PT-R05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1