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

Model Number	63-SP-9005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that the center load rod inserter mis 3l (63-sp-9005) broke during a procedure.Multiple attempts to obtain details were unsuccessful.
Event or Problem Description
It was reported that the center load rod inserter mis 3l (63-sp-9005) broke during a procedure.Multiple attempts to obtain details were unsuccessful.
Additional Manufacturer Narrative
H3 device evaluation - the inserter was returned for evaluation with one side of the distal tip fractured, the other side intact.The laser markings are worn and faded.The gold knob was returned in the fully retracted position and functional.The condition of the fracture location is in agreement with the results concluded in testing reports, in which the inserter is overloaded to 160 in-lbs.Review of device history records ((b)(4)) found (b)(4) pieces of lot 00116pt released for distribution on 6/24/2019 with no deviation or anomalies.Two-year complaint history review did not reveal 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 to an excessive load (torque) applied to the instrument.In response to a previous report of this nature, a quick reference guide (attached) was circulated to mis 3l users to mitigate future occurrences.This guide illustrates proper center load rod inserter technique.

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 17050662
• Report Number: 3005739886-2023-00024
• Device Sequence Number: 3480103
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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