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

Model Number	63-SP-9005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Lot number: unknown.Occupation: other; sales representative.Device manufacture date: unknown as lot number was not provided device evaluation: as the product was not returned for evaluation no conclusions can be drawn regarding the reported malfunction.Should the product be returned, a follow-up medwatch report will be filed.
Event or Problem Description
It was reported that during a procedure performed (b)(6) 2020, the doctor hand tightened the l5, s1 set screws on the patient's left side using the cap screw inserter and ratcheting palm handle.With the rod inserter still attached to the rod, they heard a pop while hand tightening the set screw on l4.They realized that the rod inserter had broken off in-situ and confirmed it via fluoro.They were able to fish out the broken piece of the inserter and finish up the surgery without any other further issue.
Event or Problem Description
It was reported that during a procedure performed (b)(6) 2020, the doctor hand tightened the l5, s1 set screws on the patient's left side using the cap screw inserter and ratcheting palm handle.With the rod inserter still attached to the rod, they heard a pop while hand tightening the set screw on l4.They realized that the rod inserter had broken off in-situ and confirmed it via fluoro.They were able to fish out the broken piece of the inserter and finish up the surgery without any other further issue.
Additional Manufacturer Narrative
H3: device evaluation - the inserter was returned for evaluation without the distal fractured tip.Other than the fracture location, the inserter has scuff marks on the outside flat surfaces typical of an inserter that has been in the field for over a year.The condition of the fracture location is in agreement with the results concluded in an fea - fracture mechanic study conducted on this instrument design, 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 found twenty-six (26) pieces of lot 00116pt-r were released for distribution on 5/30/2019 with no deviation or anomalies.

• Brand Name: SURELOK MIS 3L
• Common Device Name: INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 10326827
• Report Number: 3005739886-2020-00019
• Device Sequence Number: 3574296
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/01/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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