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

Catalog Number	39-SP-0700
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform pedicle screw system.While removing a 7.5mm screw from s1 on the patient's left side, the t20, polyaxial driver, reform degen (39-sp-0700) tip broke.The driver was not screwed down and engaged with the screw when the breakage occurred.Subsequently, we cut a rod from the patient that had been removed from the right side already.Surgeon then placed the rod into the s1 screw on the left and torqued it down.The pa, then used the counter torque to spin the screw counterclockwise and remove using the "helicopter" method.There was no patient injury, and the procedure was completed successfully.
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the 39-sp-0700 driver is sheared off.The breakage plane is normal to the driver's longitudinal axis which is one failure mode associated with torsional overload.The cause for the failure appears to be due to high torque application, but damage from prior high torque application cannot be ruled out as a contributing factor.Review of device history records found twelve (12) pieces of this lot released for distribution on 6/26/2015 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for this part number.No corrective actions are being recommended.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform pedicle screw system.While removing a 7.5mm screw from s1 on the right side the tip of the reform driver with mechanical lock (hxx-39-0001) bent.The driver was screwed down and engaged with the screw.While removing a 7.5mm screw from s1 on the patient's left side, the t20, polyaxial driver, reform degen (39-sp-0700) tip broke.The driver was not screwed down and engaged with the screw when the breakage occurred.Subsequently, we cut a rod from the patient that had been removed from the right side already.Surgeon then placed the rod into the s1 screw on the left and torqued it down.The pa, then used the counter torque to spin the screw counter clockwise and remove using the "helicopter" method.There was no patient injury and the procedure was completed successfully.

• 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: 18032341
• Report Number: 3005739886-2023-00059
• Device Sequence Number: 6924657
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• 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): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 3339MM-R-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown