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

Catalog Number	63-SP-9005
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unknown.Occupation: other; distributor.Product evaluation: product is being returned but has yet to be received.Upon receipt and following investigation completion, a follow-up medwatch will be submitted.
Event or Problem Description
It was reported that an alif 360 procedure was performed on (b)(6) 2019, utilizing the surlok mis 3l pedicle screw system.During the procedure the sl rod inserter was retrieved and the scrub tech tried to engage the rod into the inserter without success.The 3.5mm hex driver was seated and an attempt to turn the gold knob found it to be stuck.The surgeon attempted to freehand loosen it and also attempted with a wrench/pliers but still was unable to loosen the knob.The procedure was completed by the doctor utilizing wax to hold the rod steady in the inserter.There was no patient injury and a delay of procedure of approximately 3-5 minutes reported.
Additional Manufacturer Narrative
H3 device evaluation - the 63-sp-9005 was returned locked in the fully retracted position.The gold knob was fixtured in a table vise and rotated the handle of the inserter in a manner that successfully loosened the gold knob.Once the knob was loosened, the 63-sp-9005 functioned as intended.Root cause stems from excessive torque applied in a counter clockwise manner to the gold knob, possibly during disengagement of the inserter from the rod implant.Due to improper use, no corrective action is required.Review of device history record found twenty-six (26) pieces of lot 00116pt-r were released for distribution on (b)(6) 2019 with no deviation or anomalies.Two-year complaint history review (9.24.2017-9.24.2019) found this to be the only report for this lot.Due to improper use, no corrective action is required.
Event or Problem Description
It was reported that an alif 360 procedure was performed on (b)(6) 2019, utilizing the surlok mis 3l pedicle screw system.During the procedure the sl rod inserter was retrieved and the scrub tech tried to engage the rod into the inserter without success.The 3.5mm hex driver was seated and an attempt to turn the gold knob found it to be stuck.The surgeon attempted to freehand loosen it and also attempted with a wrench/pliers but still was unable to loosen the knob.The procedure was completed by the doctor utilizing wax to hold the rod steady in the inserter.There was no patient injury and a delay of procedure of approximately 3-5 minutes reported.

• Brand Name: SURELOK MIS 3L
• Common Device Name: CL ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9203016
• Report Number: 3005739886-2019-00045
• Device Sequence Number: 2579458
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 00116PT-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1