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

Catalog Number	59-SP-0601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024 utilizing the reform mc screw system.During the procedure the t25, adjustable driver; reform mc screw system (59-sp-0601) tip broke.The broken tip was removed from the screw and the procedure was completed utilizing other instrumentation readily available.There was no patient injury, but a fifteen (15) minute delay to the procedure resulted from the malfunction.
Additional Manufacturer Narrative
H3 - device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024 utilizing the reform mc screw system.During the procedure the t25, adjustable driver; reform mc screw system (59-sp-0601) tip broke.The broken tip was removed from the screw and the procedure was completed utilizing other intrumentation readily available.There was no patient injury, but a fifteen (15) minute delay to the procedure resulted from the malfunction.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was reviewed by eye and with the aid of a 5x loop.The tip is fractured in a plane that is normal to the driver's longitudinal axis.This type of fracture is indicative of a failure due to a torsional overload, but damage from prior high torque application can not be ruled out as a potential contributing factor.Review of device history records found (b)(4) pieces of this lot released for distribution on 12/6/2019 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.

• Brand Name: REFORM MC 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: 19810827
• Report Number: 3005739886-2024-00041
• Device Sequence Number: 8349002
• Product Code: HXX
• UDI-Device Identifier: 00840019927987
• UDI-Public: 00840019927987
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 59-SP-0601
• Device Lot Number: 35758PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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