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	01/27/2021
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
It was reported that a procedure was performed utilizing the surelok mis 3l system.The first rod was loaded normally on to the inserter and then successfully implanted using the inserter.The surgeon had difficulty removing the inserter from the rod using the green torque limited driver, but ultimately was able to free it with no negative impact to the patient or implants.On the back table the scrub tech noted that the gold nob on the inserter was not turning.They used sterile instruments to try to turn the knob, but were unable to get any movement.The second rod was implanted using a normal open rod inserter, no attempt to use this part was made again.There was no injury to the patient or delay to the procedure reported.
Additional Manufacturer Narrative
Device evaluation - the inserter was returned for evaluation with the gold knob frozen in the fully counter-clock-wise direction.The laser markings are crisp and legible.Given the information provided, it is likely the surgeon froze the knob when using the green handle torque driver by supplying more counter-clock-wise torque than that handle is capable of supplying in the clock-wise direction due to the torque limit feature.The knobwas able to be loosened during this investigation using a non-torque limit device.Once loosened, the inserter functions as intended.Review of device history records found ten (10) pieces of lot 00188pt were released for distribution on 10/19/2020 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 (counter-clock-wise torque) applied to the instrument.
Event or Problem Description
It was reported that a procedure was performed utilizing the surelok mis 3l system.The first rod was loaded normally on to the inserter and then successfully implanted using the inserter.The surgeon had difficulty removing the inserter from the rod using the green torque limited driver, but ultimately was able to free it with no negative impact to the patient or implants.On the back table the scrub tech noted that the gold nob on the inserter was not turning.They used sterile instruments to try to turn the knob, but were unable to get any movement.The second rod was implanted using a normal open rod inserter, no attempt to use this part was made again.There was no injury to the patient or delay to the procedure reported.

• 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: 11359694
• Report Number: 3005739886-2021-00012
• Device Sequence Number: 14246015
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• 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): 01/27/2021

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: 00188PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/22/2021
• 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