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

Model Number	63-SP-9005
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the surelok mis 3l pedicle screw system.While attempting to insert the second rod, the tip of the cl rod inserter (63-sp-9005) broke.The doctor had to make a larger wiltse incision, and the broken piece was removed with forceps and the rod was inserted using a rod inserter pulled from another instrument tray.There was no patient injury reported, but a fifteen-minute (15) delay due to the malfunction of the rod inserter.
Additional Manufacturer Narrative
Reporter occupation: sales representative.Type of reportable event - serious injury due to the need for medical intervention in extending the incision and removing the broken inserter tip device evaluation - although information provided indicates that the product is available for evaluation, it has not yet been returned.Should the product be received, a follow-up medwatch report will be filed upon completion of the investigation.No conclusions as to the cause of the breakage can be drawn at this time.Review of device history records found that twenty-six (26) pieces of lot 00116pt-r release for distribution on 5/30/2019 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 actions are recommended.
Additional Manufacturer Narrative
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 testing 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.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the surelok mis 3l pedicle screw system.While attempting to insert the second rod, the tip of the cl rod inserter (63-sp-9005) broke.The doctor had to make a larger wiltse incision, and the broken piece was removed with forceps and the rod was inserted using a rod inserter pulled from another instrument tray.There was no patient injury reported, but a fifteen-minute (15) delay due to the malfunction of the rod inserter.

• 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: 15103272
• Report Number: 3005739886-2022-00023
• Device Sequence Number: 11909151
• 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): 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown