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

Model Number	39-RD-0060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 primary unique device identifier (udi) number - udi for this part number does not include lot or batch number, serial number, expiration date or manufacturing date.H3 device evaluation - the 39-rd-0060 driver was returned with its tip missing.The fracture plane is skewed relative to the driver's longitudinal axis.This type of fracture is indicative of a failure due to combination loading.Torsion loading in combination with bending moments is suspected as the cause for this failure.Multiple fracture planes are present.It is not known if the failure was solely the result of applied loading during this procedure or if the failure initiated from a crack from prior high force application.Review of device history records found a total of thirty-one (31) pieces of this lot released for distribution on 6/3/2021 (8 pcs) and 6/26/2021 (23 pcs) with no deviation or anomalies that would relate to the reported failure.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being recommended since the failure appears to be the result of combination loading, proper counter torque usage would mitigate bending moments acting on the tip, the failure does not appear to be manufacturing related.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024.During the procedure the tip of a t25, lock-screw torque driver, reform (39-rd-0060) and a t25 driver, persuader, long (c3492) both broke.The tips were recovered and the procedure was successfully completed utilizing other instrumentation readily available.There was no patient injury or delay to the procedure.

• 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: 20902594
• Report Number: 3005739886-2024-00063
• Device Sequence Number: 15716593
• 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): 11/25/2024

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 Model Number: 39-RD-0060
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 48680PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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