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

Model Number	63-SP-9005
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Date of event - 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
Regulatory was notified by distribution that a cl rod inserter (63-sp-9005) was returned with a broken tip.Requests for additional details have been unsuccessful to date.
Additional Manufacturer Narrative
Additional information was received on may 10, 2021.This follow-up report will provide corrected and additional data not contained in the initial report.Product evaluation is not complete at this time.A second follow-up report will be filed when the investigation is complete.Corrected data - b1 & b2 - changed from product problem, to adverse event, due to medical intervention required to remove the broken tip from the patient.H1 - changed from malfunction to serious injury additional information - b3 & b5 - updated to provide new event information received.G7 - added fu & fu#.H2 checked for additional information.
Event or Problem Description
It was reported that a procedure was performed on (b)(6), 2021, utilizing the surlok mis 3l pedicle screw system.The rod had been inserted and the locking caps placed and torqued when the tip of the cl rod inserter ((b)(6)) broke off.The broken tip was removed using hemostats, and the procedure completed successfully with no patient injury or delay.
Event or Problem Description
It was reported that a procedure was performed on (b)(6), 2021, utilizing the surlok mis 3l pedicle screw system.The rod had been inserted and the locking caps placed and torqued when the tip of the cl rod inserter ((b)(6)) broke off.The broken tip was removed using hemostats, and the procedure completed successfully with no patient injury or delay.
Additional Manufacturer Narrative
H3 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 during testing, in which the inserter is overloaded to 160 in-lbs.Review of device history records found that a total of twenty-three (23) pieces of lot 17020ap-r05 were release for distribution between (b)(6) 2018 & (b)(6) 2018 with no deviation or anomalies.Review of complaint history back to the date of manufacture (4.16.2021) found one previous report of this nature for the reported lot 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.

• 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: 11764378
• Report Number: 3005739886-2021-00027
• Device Sequence Number: 17201062
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 04/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 63-SP-9005
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 17020AP-R05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 04/07/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/24/2021; 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention