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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 3 of 3 mdrs filed for the same event (reference 3005739886-2021-00059).
Event or Problem Description
It was reported that a three-level procedure was performed in (b)(6) on (b)(6) 2021, utilizing the reform pedicle screw system.While the surgeon was locking the lock screw the tips of two lock-screw torque drivers (39-rd-0060) broke.The tip of a t20, retention bone-screw driver, reform (39-sp-0601) also broke.All broken tips were removed and all lock screws were successfully tightened using the torque limiting handle.There was no patient injury or delay to the procedure resulting from these failures.
Event or Problem Description
It was reported that a three-level procedure was performed in (b)(6) on (b)(6), 2021, utilizing the reform pedicle screw system.While the surgeon was locking the lock screw the tips of two lock-screw torque drivers (39-rd-0060) broke.The tip of a t20, retention bone-screw driver, reform (39-sp-0601) also broke.All broken tips were removed and all lock screws were successfully tightened using the torque limiting handle.There was no patient injury or delay to the procedure resulting from these failures.
Additional Manufacturer Narrative
H3 device evaluation - according to the complaint information provided, the t20, retention bone-screw driver, reform broke while attempting to tighten a t25 lock screw.The root cause of the reported tip breakage it attributed to use error, as this driver is not intended to be used with a t25 hex.Review of device history records found fifty-four (54) pieces of this lot were released for distribution on 2/7/2017 with no deviation or anomalies.Two-year complaint history review (10.18.2019-10.18.2021) did not identify a trend for reports of this nature for this part number.No corrective actions are recommended.This report is number 3 of 3 mdrs filed for the same event (reference (b)(4)).

• 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: 12796741
• Report Number: 3005739886-2021-00061
• Device Sequence Number: 3961650
• 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): 10/18/2021

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: 12338PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• 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