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

Model Number	63-SP-9005
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Other serious (important medical events) - this is being reported as a serious injury (retained foreign object) due to the fractured tip of the rod inserter being left in the patient.Occupation - other; operations supervisor and sales coordinator.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a tlif l4-l5 procedure was performed on (b)(6) 2021, in (b)(6).While placing the second rod, after the six (2) screws and the first rod, the surgeon was trying to insert the rod through the screws when the cl rod inserter (63-sp-9005) tip broke inside the patient and was no longer holding the rod.The surgeon managed to insert the locking cap on one of the screw to hold the rod in place.Attempts to remove the broken tip were unsuccessful.There was a delay to the procedure of approximately thirty (30) minutes.
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 testing in which the inserter is overloaded to 160 in-lbs.Review of device history records found ten (10) pieces of lot 00188pt were released for distribution on 10/19/2020 with no deviation or anomalies.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 tlif l4-l5 procedure was performed on (b)(6) 2021, in dubai.While placing the second rod, after the six (2) screws and the first rod, the surgeon was trying to insert the rod through the screws when the cl rod inserter (63-sp-9005) tip broke inside the patient and was no longer holding the rod.The surgeon managed to insert the locking cap on one of the screw to hold the rod in place.Attempts to remove the broken tip were unsuccessful.There was a delay to the procedure of approximately thrity (30) minutes.

• 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: 12080503
• Report Number: 3005739886-2021-00039
• Device Sequence Number: 14319079
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 63-SP-9005
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 00188PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: Other