MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	39-SP-0601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tlif l4-5 with bl screw placement was performed on (b)(6) 2023, utilizing the reform pedicle screw system.Incision made, expoure, burr, 3.2mm drill into pedicle, 6.5mm precision tap, 6/5 x 40mm ht screws with 45mm lt rod and lock screws (x2) were placed, without final tightening of lock screws.The second rod and lock screws were then placed utilizing the t20, retention bone-screw driver, reform (39-sp-0601), counter torque wrench and the offset ratcheting torque handle was used successfully on two (2) screws.When attempting to final tighten the left l5 lock screw the tip of the driver broke.The broken tip was removed from the lock screw and the second driver, readily available in the set, was used to successfully complete the procedure.X-rays were performed to verify no fragments remained in the patient.There was no patient injury or delay to the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - the driver has its tip sheared off.The fracture is in a plane that is perpendicular to the driver's longitudinal axis.This failure mode is consistent with a torsional overload failure.No signs of combination loading are observed by eye or with the aid of a 5x loop, but crack initiation from prior combination loading cannot be ruled out.It was noted that the driver was being used to tighten lock screws.This driver has a t20 drive feature that is capable of mating with 39-ls-0100 lock screw as well as 39-pa-xxxx, polyaxial screws.The design is intended to function as an adjustment bone screw driver and while it will fit inside a counter torque wrench the design has extra clearance with the counter torque wrench as compared to the lock screw final tightener, 39-rd-0060.Review of device history records found (b)(4) pieces of lot 0002up released for distribution on 9/17/2014 with no deviation or anomaly that would relate to the reported malfunction.Two-year complaint history review (6.12.2021-6.12.2023) found this to be the only report for this lot.Further review did not identify a trend for reports of this nature for this part number.No corrective actions are recommended at this time.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 17289249
• Report Number: 3005739886-2023-00026
• Device Sequence Number: 5537066
• Product Code: HXX
• UDI-Device Identifier: 00840019928700
• UDI-Public: 00840019928700
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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 Model Number: 39-SP-0601
• Device Catalogue Number: 39-SP-0601
• Device Lot Number: 0002UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown