MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM PEDICLE SCREW SYSTEM; TORQUE LIMITING HANDLE

Catalog Number	39-CH-0008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an l4-l5 posterior lumbar fusion was performed on (b)(6) 2023, utilizing the reform pedicle screw system.In the final step, the doctor retrieved the standard torque handle (39-ch-0008) with a standard shaft (39-rd-0060).The initial left and right side screws were (39-sb-6540 & 6545) were solidly placed in all four (4) pedicles.Four (4) modular polyaxial tulip assemblies (64-mt-0403) were then attached.A 40mm rod (63-lt-5040) was placed in the tulip.Set screws (39-ls-0100) were then placed down the l4 tulip until force was initiated that would result in the force limit on the torque limiting handle to release.Upon making the final forced turn, the shaft of the driver sheared off in the set screw.The doctor was able to retrieve the broken metal.The handle/driver combo was then exchanged from a back-up tray and all four (4) set screw functioned correctly.There was no delay to the procedure resulting from the reported malfunction.
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 2 of 2 mdrs filed for the same event (reference 3005739886-2024-00005.
Additional Manufacturer Narrative
H3 device evaluation - evaluation of the returned 39-ch-0008 / offset ratcheting torque handle lot 11485gb021 found the torque release to be within the 106 in/lbs +/- 10% design specifications.A review of the ratcheting handle other than the prior review by quality identifying that it was within specification did not yield any new findings.The ratcheting handle's ability to attach, ratchet in both directions and remain fixed when in that setting all support proper function of that device.Review of device history records found twenty-two (22) pieces of lot 11485gb (serialized 1 thru 22) released for distribution on 2/19/2016 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.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2024-00005-1 i 00006-1).
Event or Problem Description
It was reported that an l4-l5 posterior lumbar fusion was performed on (b)(6) 2023, utilizing the reform pedicle screw system.In the final step, the doctor retrieved the standard torque handle (39-ch-0008) with a standard shaft (39-rd-0060).The initial left and right side screws were (39-sb-6540 & 6545) were solidly placed in all four (4) pedicles.Four (4) modular polyaxial tulip assemblies (64-mt-0403) were then attached.A 40mm rod (63-lt-5040) was placed in the tulip.Set screws (39-ls-0100) were then placed down the l4 tulip until force was initiated that would result in the force limit on the torque limiting handle to release.Upon making the final forced turn, the shaft of the driver sheared off in the set screw.The doctor was able to retrieve the broken metal.The handle/driver combo was then exchanged from a back-up tray and all four (4) set screw functioned correctly.There was no delay to the procedure resulting from the reported malfunction.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: TORQUE LIMITING HANDLE
• 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: 18563362
• Report Number: 3005739886-2024-00006
• Device Sequence Number: 15483070
• Product Code: LXH
• UDI-Device Identifier: 00840019928212
• UDI-Public: 00840019928212
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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-CH-0008
• Device Lot Number: 11485GB021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2016
• 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