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

Catalog Number	39-RD-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision procedure to extend an existing construct was performed on (b)(6) 2024, utilizing the reform pedicle screw system.During the procedure while attempting to remove the existing lock screws, the tips of two (2) t25, lock-screw torque driver, reform (39-rd-0060) broke.The tips were recovered and the procedure was complete utilizing other instrumentation readily available.There was no patient injury or delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - both driver's tips are fractured.Both fractures are skewed relative to the drivers' longitudinal axis.This type of failure is typical of parts failing due to combination loading.It is expected that bending moments in combination with torsional loads resulted in the observed failures.These components have been available for use for approximately nine and three years so crack initiation from prior usage can not be ruled out as a contributing factor associated with the observed failures.Review of device history records found thirty-one (31) pieces of this lot released for distribution on 6/3/2021 (8pcs) and 6/26/2021 (23 pcs) with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being commended since the failures do not appear to be manufacturing related.

• 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: 19629190
• Report Number: 3005739886-2024-00032
• Device Sequence Number: 7146491
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• 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): 06/04/2024

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: 39-RD-0060
• Device Lot Number: 24111TY01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2015
• 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