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	09/18/2024
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.D9 is this device available for evaluation - no.Although initial information received indicates that the product will be returned, it has yet to be received.H3 device evaluation - without the opportunity to evaluate the complaint product, no conclusions can be drawn.Review of device history records found (b)(4) pieces of lot 18994ps released for distribution on 7/23/2018 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.Should the product be received, a follow-up medwatch report will be filed upon completion of evaluation.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the reform pedicle screw system.While final tightening the lock screws the tip of the t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip was removed using a rongeur and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury, but a five (5) minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the 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 combination loading.It is believed that the driver fractured as a result of torque in combination with bending moment loads being applied during its usage history.The fracture surface was examined with a 5x loop.The fracture surface includes multiple fracture planes.It is unclear if the fracture was a direct result of forces applied during this particular procedure or if fracture was initiated during prior usage and manifested itself during this procedure.This type of failure is noted in risk documentation.No corrective actions are being recommended since the failure appears to be a result of combination loading, proper counter torque wrench usage would mitigate bending moments acting on the driver tip, and 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, utilizing the reform pedicle screw system.While final removed using a rongeur and the procedure was completed utilizing the second driver readily available in the set.There was no patient injury, but a five (5) minute 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: 20476057
• Report Number: 3005739886-2024-00048
• Device Sequence Number: 7471866
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2024

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: 189994PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2018
• 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