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	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupaton - 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
Information provided indicates that a procedure was performed on (b)(6) 2020, utilizing the surelok mis 3l pedicle screw system.The rod was assembled onto the inserter and the surgeon was threading it through the mis screw towers and on its way down to seat it, the cl rod inserter (63-sp-9005) broke upon maneuvering.The tip was recovered and the rod was successfully placed using a kocher.There was a thirty (30) minute delay to the procedure due to having to retrieve the broken tip and use the kocher for rod insertion.
Event or Problem Description
Information provided indicates that a procedure was performed on (b)(6) 2020, utilizing the surelok mis 3l pedicle screw system.The rod was assembled onto the inserter and the surgeon was threading it through the mis screw towers and on its way down to seat it, the cl rod inserter (63-sp-9005) broke upon maneuvering.The tip was recovered and the rod was successfully placed using a kocher.There was a thirty (30) minute delay to the procedure due to having to retrieve the broken tip and use the kocher for rod insertion.
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 in the attached report 1116191-cn04-rev0 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.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: 10886894
• Report Number: 3005739886-2020-00037
• Device Sequence Number: 3005057
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/29/2020

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
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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