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  Injury  

Manufacturer Narrative

B2 - other serious or important medical events - this is being reported as a serious injury (retained foreign object) due to the fractured tip of two drivers being left in the lock screw implanted in the patient.H3 - device evaluation in process.A follow-up report will be submitted upon completion.This report is number 1 of 4 mdrs filed for the same event (reference 3005739886-2024-00001 / 00004).

Event Description

It was reported that a 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, offset ratcheting torque handle (39-ch-0008) with the standard shaft, t25, lock-screw torque driver, reform (39-rd-0060).The initial l4/left side screw was (39-sb-6545) along with a modular polyaxial tulip assembly (64-mt-0403) was solidly placed in the pedicle.After the left side screw was placed (39-sb-6550), a 40mm rod (63-lt-5040) was place 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 sheared off with complete tip remaining in the set screw.The handle/shaft combo was then exchanged from a back-up tray.Again, force was used on the set screw with the same result, complete shearing of the tip.With both tips determined to be "cold welded", as many retrieval efforts were unsuccessful, the tips remained in each tulip and the surgeon completed the procedure.The two (2) final set screws on the right side functioned correctly.There was a twenty-minute (20) delay to the procedure as a result of the reported malfunctions.

Manufacturer Narrative

H3 device evaluation - both 39-rd-0060 drivers have their tip sheared off.The fracture plane is skewed relative to the driver's longitudinal axis which is indicative of failure due to combination loading.Loading due to torque application in combination with bending moments likely lead to the failure but crack initiation from prior usage cannot be ruled out as a contributing factor.It is unclear if a counter torque wrench was being used.Proper use of the counter torque would mitigate bending moment application.The fact that the ratcheting torque handle was out of spec accounts for potential excessive torque application.Review of device history records found a total of thirty (30) pieces of this lot released for distribution on 10/22/2013 (17 pcs) and 10/23/2013 (15 pcs) 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 4 mdrs filed for the same event (reference (b)(4).

Event Description

It was reported that a 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, offset ratcheting torque handle (39-ch-0008) with the standard shaft, t25, lock-screw torque driver, reform (39-rd-0060).The initial l4/left side screw was (39-sb-6545) along with a modular polyaxial tulip assembly (64-mt-0403) was solidly placed in the pedicle.After the left side screw was placed (39- sb-6550), a 40mm rod (63-lt-5040) was place 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 sheared off with complete tip remaining in the set screw.The handle/shaft combo was then exchanged from a back-up tray.Again, force was used on the set screw with the same result, complete shearing of the tip.With both tips determined to be "cold welded", as many retrieval efforts were unsuccessful, the tips remained in each tulip and the surgeon completed the procedure.The two (2) final set screws on the right side functioned correctly.There was a twenty-minute (20) delay to the procedure as a result of the reported malfunctions.

• 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: 18558630
• MDR Text Key: 333438893
• Report Number: 3005739886-2024-00001
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-RD-0060
• Device Lot Number: 053IT
• 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: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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
• Patient Outcome(s): Other
• Patient Sex: Female