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

Catalog Number 39-RD-0060

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

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 1 of 2 mdrs filed for the same event (reference 3005739886-2024- 00006).

Event 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.

Manufacturer Narrative

H3 device evaluation - the 39-rd-0060 driver tip fracture plane is sharply skewed relative to the driver's longitudinal axis which is indicative of a failure due to combination loading.It is believed that bending moments were applied during torque application which resulted in part fracture but the fracture may have been initiated in prior usage with combination loading applied.It is unclear if a counter torque wrench was being used as proper use of this device would help mitigate bending moment application.Review of device history records found eleven (11) pieces of this lot released for distribution on (b)(6) 2020 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 1 of 2 mdrs filed for the same event (reference 3005739886-2024-00005-1 i 00006-1).

Event Description

It was reported that an l4-l5 posterior lumbar fusion was performed on december 26, 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
• Type of Device: 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: 18563363
• MDR Text Key: 333541630
• Report Number: 3005739886-2024-00005
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019928366
• UDI-Public: 00840019928366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 1213TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 12/27/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1