MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTE; 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	06/12/2024
Type of Reportable Event	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 perfomred in the dominican republic on (b)(6) 2024, utilizing the reform pedicle screw system.Upon assemblying the lock screws the doctor placed the anti-torque and when applying final torque, the tip of the t25, lock-screw torque driver, reform (30-rd-0060) broke.The broken tip was removed and the lock screw was final tightened utilizing the second driver readily available in the set.Subsequently, upon tightening the final lock screw, the tip of the second t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip piece was removed and the lock screw ultimately tightened using the lock screw retention drive (39-rd-0602) with hand pressure.There was no patient injury, but a ten (10) minute delay to the procedure.
Event or Problem Description
It was reported that a procedure was performed in the (b)(6) on (b)(6) 2024, utilizing the reform pedicle screw system.Upon assembling the lock screws the doctor placed the anti-torque and when applying final torque, the tip of the t25, lock-screw torque driver, reform (30-rd-0060) broke.The broken tip was removed and the lock screw was final tightened utilizing the second driver readily available in the set.Subsequently, upon tightening the final lock screw, the tip of the second t25, lock-screw torque driver, reform (39-rd-0060) broke.The broken tip piece was removed and the lock screw ultimately tightened using the lock screw retention drive (39-rd-0602) with hand pressure.There was no patient injury, but a ten (10) minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation : both drivers were examined by eye and with the aid of a 10x loop.The tips are missing from both drivers with the fracture surfaces skewed relative to the driver's longitudinal axis with multiple fracture planes present.This type of breakage is typical of failures due to combination loading.It is suspected that bending moments were applied in combination with the applied tightening torque which resulted in the observed failures.It was noted that a counter torque wrench was used so it is unclear if damage from prior usage manifested itself in these failures.Proper counter torque wrench usage mitigates bending moments acting on the driver's tip.Review of device history records found (b)(4) pieces of this lot released for distribution on 11/6/2023 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.

• Brand Name: REFORM PEDICLE SCREW SYSTE
• 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: 19731397
• Report Number: 3005739886-2024-00038
• Device Sequence Number: 18175300
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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 Catalogue Number: 39-RD-0060
• Device Lot Number: 01008UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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