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

Model Number	39-HT-7535
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Initial reporter: occupation - other; distributor.Device evaluation - although information provided indicates that the driver is available for evaluation, it has not yet been received by the manufacturer, therefore, no conclusions can be drawn at this time.Review of device history records found ((b)(4)) pieces of this lot released for distribution on 7/12/2021 with no deviations or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for this part number.Should the product be received a follow-up medwatch report will be submitted to provide evaluation results.This report is number 4 of 4 mdrs filed for the same event (reference 3005739886-2021-00055).
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6) 2021, in which reform ti pedicle screw system product was implanted.Subsequently, it was identified that at least one of the pedicle screws was noted to be loose and a revision procedure was performed on (b)(6) 2021, in which three (3) of the (4) screws implanted were remove and replaced with a competitor's screws.During the revision procedure when attempting to remove one of the previously torqued lock screws, the tip of the lock-screw torque driver (39-rd-0060) broke off.The tip was removed, and the procedure successfully completed utilizing the second driver, readily available in the set.Screws removed were discarded at the hospital.As it is unknown which of the three screws removed were loose, all three are being reported.
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6) 2021, in which reform ti pedicle screw system product was implanted.Subsequently, it was identified that at least one of the pedicle screws was noted to be loose and a revision procedure was performed on (b)(6) 2021, in which three (3) of the (4) screws implanted were remove and replaced with a competitor's screws.During the revision procedure when attempting to remove one of the previously torqued lock screws, the tip of the lock-screw torque driver (39-rd-0060) broke off.The tip was removed, and the procedure successfully completed utilizing the second driver, readily available in the set.Screws removed were discarded at the hospital.As it is unknown which of the three screws removed were loose, all three are being reported.
Additional Manufacturer Narrative
H3 device evaluation - engineering review of fracture surface images indicate driver failure is due to excessive torque in a counterclockwise direction.As the torque handle limits torque only the clockwise direction, it is reasonable to assume the application of excessive torque while removing a previously torqued lock screw is the root cause of the failure.No corrective actions are recommended.

• 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: 12691129
• Report Number: 3005739886-2021-00058
• Device Sequence Number: 4265571
• Product Code: HXX
• UDI-Device Identifier: 00815362029190
• UDI-Public: 00815362029190
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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-HT-7535
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 12877TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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