MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW; SCREWDRIVER

Model Number	64-SP-0601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 3 of 4 mdrs filed for the same event (reference 3005739886-2023-00030 / 00033).
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti mis ct pedicle screw system.Upon screw insertion the tip of two polyaxial driver assembly, cannulated reform mis system (64-sp-1700), and one adjustment driver, reform mis pedicle system (64-sp-1700) broke.A ø7.5mm x 45mm reform ti modular cannulated screw (64-sp-7545) also sheared at the neck.The sheared screw was removed and replaced.No broken tips were left in the patient, but there was a 45-55 minute delay to the procedure due to the malfunctions.
Additional Manufacturer Narrative
H3 device evaluation: the adjustment driver also has its hexalobe sheared off but the remnant hexabobe is twisted in a manner that is consistent counterclockwise torque application (backing an implant out).It is unclear if this driver was being used to back out a screw during this procedure or if the driver had been damaged in a prior procedure and ultimately failed during this usage.No signs of failure due to combination loading were observed.The failure is consistent with failure due to high torque application since the failure plane is normal to the driver's longitudinal axis.Crack initiation from prior high torque application cannot be ruled out as a cause for the failure observed in the given procedure.A review of the device history records (manufacturing and inspection records), and a review of failures for this lot did not bring any manufacturing related anomalies to light.The cause for the failures is undetermined but is believed to be due to high torque application.No corrective actions are being recommended.This report is number 3 of 4 mdrs filed for the same event (reference 3005739886-2023-00030-1 / 00033-1).
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti mis ct pedicle screw system.Upon screw insertion the tip of two polyaxial driver assembly, cannulated reform mis system (64-sp-1700) and one adjustment drive, reform mis pedicle system (64-sp-0601) broke.A 07.5mm x 45mm reform ti modular cannulated screw (64-sk-7545) also sheared at the neck.The sheared screw was removed and replaced.No broken tips were left in the patient, but there was a 45-55 minute delay to the procedure due to the malfunctions.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW
• 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: 17337172
• Report Number: 3005739886-2023-00032
• Device Sequence Number: 15107519
• Product Code: HXX
• UDI-Device Identifier: 00840019942461
• UDI-Public: 00840019942461
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/22/2023

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 Model Number: 64-SP-0601
• Device Catalogue Number: 64-SP-0601
• Device Lot Number: 00948UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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