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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a 2-level tlif procedure, performed on an unknown date, the cl rod inserter (63-sp-9005) broke during final tightening of the last lock screw.The tip was recovered and discarded by surgical staff and the procedure was completed utilizing a backup rod inserter.They was no delay to the procedure or harm to the patient.
Additional Manufacturer Narrative
Occupation - other; sales representative.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.The condition of the fracture location is in agreement with the results concluded in the attached report (b)(4) in which the inserter is overloaded to 160 in-lbs.Review of device history records found ten (10) pieces of lot 00188pt released for distribution on (b)(6) 2020 with no deviation or anomalies.Complaint history review did not identify a trend for reports of this nature for this part number.No corrective action is recommended at this time due to the likelihood the failure can be attributed (root cause) to an excessive load (torque) applied to the instrument.

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 14305033
• Report Number: 3005739886-2022-00014
• Device Sequence Number: 4705760
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/18/2022

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: 04/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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
• Patient Sex: Unknown