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	08/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, in saudi arabia, utilizing the surelok mis 3l pedicle screw system.During the procedure after the rod was inserted and the lock screws tightened, upon attempts to loosen the cl rod inserter (63-sp-9005) to release the rod it did not release.While manipulating the inserter for removal the tip broke.The broken tip was removed, and the procedure was completed utilizing the second inserter readily available in the set.As a result, there was a 15-30-minute delay to the procedure.
Additional Manufacturer Narrative
Device evaluation - although the information provided indicates that they product is available for evaluation, it has yet to be received.Once received a follow-up medwatch report will be filed following investigation.
Additional Manufacturer Narrative
H3 device evaluation - the inserter was returned for evaluation without the distal fractured tip.The laser markings are crisp and legible.The gold knob was stuck upon return in the fully retracted position.Significantly more torque than the 18 in-lbs that could be applied via the handle supplied in the set was required to loosen the gold knob.The condition of the fracture location is in agreement with the results concluded in testing performed in which the inserter is overloaded to 160 in-lbs.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.Review of device history records (b)(4) pieces of the reported lot were released without deviation or anomaly in april of 2018.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.
Event or Problem Description
It was reported that a procedure was performed on august 20, 2022, in (b)(6), utilizing the surelok mis 3l pedicle screw system.During the procedure after the rod was inserted and the lock screws tightened, upon attempts to loosen the cl rod inserter (63-sp-9005) to release the rod it did not release.While manipulating the inserter for removal the tip broke.The broken tip was removed, and the procedure was completed utilizing the second inserter readily available in the set.As a result, there was a 15-30-minute delay to the procedure.

• 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: 15845853
• Report Number: 3005739886-2022-00037
• Device Sequence Number: 5982230
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 34749PS-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown