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

Model Number	39-SP-0601
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Device evaluation - although information provided indicates that the product will be returned, it has yet to be received by the manufacturer.Once received and investigation is complete, a follow-up medwatch report will be submitted.This report is number 3 of 3 mdrs filed for the same event (reference 3005739886-2022-00001).
Event or Problem Description
It was reported that a procedure was performed in (b)(6), on (b)(6) 2021, utilizing the reform pedicle screw system.While tightening a lock screw, three lock-screw torque drivers (39-rd-0060) broke.The tips were all removed, and the lock screw was successfully tightened using another driver, readily available, with the torque limiting handle.There was no injury to the patient reported.
Additional Manufacturer Narrative
D4 lot # - corrected.H4 device manufacture date - corrected.H3 device evaluation - the lock screw driver was was reviewed with the aid of a 5x loop.The fracture was in a plane that was perpendicular to the driver's longitudinal axis.It also exhibits some signs that indicate it may have initiated cracks near the outer lobes in prior use that subsequently manifested in this failure.Some shiny area near a few lobes exist.The investigation notes that the most recent shipment of torque limiting handles (39-ch-0008) to wafacare was in september of 2019.It is not known if the torque handle used was within device specifications of 106 in-lbs.± 10%.Prior testing of the design included a minimum failure load of 170.8 in-lbs.Which is well above the torque specification.Although it is unknown if the torque handle was within device specification, the fact that this distributor is not reporting an unusual number of failed drivers would suggest that the handle remains within specification for torque release.Review of device history record found one (1) piece of lot 33966mm-r released for distribution on 12/31/2019 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended at this time.This report is number 3 of 3 mdrs filed for the same event (reference 3005739886-2022-00001-1 / 00003-1).
Event or Problem Description
It was reported that a procedure was performed in saudi arabia, on september 6, 2021, utilizing the reform pedicle screw system.While tightening a lock screw, three lock-screw torque drivers (39-rd-0060) broke.The tips were all removed, and the lock screw was successfully tightened using another driver, readily available, with the torque limiting handle.There was no injury to the patient reported.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 13142576
• Report Number: 3005739886-2022-00003
• Device Sequence Number: 5387350
• Product Code: HXX
• UDI-Device Identifier: 00840019928700
• UDI-Public: 00840019928700
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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-SP-0601
• Device Catalogue Number: 39-SP-0601
• Device Lot Number: 33966MM-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• 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