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	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown.Reporter occupation other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
Information provided indicates that a procedure was performed on (b)(6) 2020 utilizing the sure-lok mis 3l pedicle screw system.During the procedure the first rod had been inserted using the cl rod inserter (63-sp-9005), after the inserter was removed from the rod it was noted that the gold knob was locked in the open position and would not attach to the second rod.Another inserter was readily available in another set and the procedure was completed successfully with no patient issue or surgical delay.
Event or Problem Description
Information provided indicates that a procedure was performed on (b)(6) 2020 utilizing the sure-lok mis 3l pedicle screw system.During the procedure the first rod had been inserted using the cl rod inserter (63-sp-9005), after the inserter was removed from the rod it was noted that the gold knob was locked in the open position and would not attach to the second rod.Another inserter was readily available in another set and the procedure was completed successfully with no patient issue or surgical delay.
Additional Manufacturer Narrative
H3 device evaluation - the inserter was received as described in the open position as described in the complaint.The knob could not be rotated with bare fingers but was able to be rotated using a 3.5mm hex driver.Once loosed, the knob can be turned with bare fingers.The feel of the threads is not smooth.The threads either sustained damage or there is debris in the mechanism or both.Also, the opening to accept the rod has experienced plastic deformation.Sides of the inserter have bent outward; the inserter can no longer pass thru the tulip as intended.This device is locked to a rod implant using a supplied handle that limits toque to 18 in-lbs.This limit prevents thread damage due to excessive input torque.Review of device history records found that (b)(6) pieces of lot 00116pt-r released for distribution on 5/30/3019 with no deviation or anomalies.Two-year complaint history review (10.20.2018-10.20.2020) found one (1) previous report of this nature for the reported lot.No corrective action is recommended at this time as cause stems from either inadequate cleaning process that does not remove internal debris or tightening with means other than the supplied torque limit device.

• 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: 10830217
• Report Number: 3005739886-2020-00035
• Device Sequence Number: 14160390
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/20/2020

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: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1