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

Model Number	HXX-39-0001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation - information received indicates that the product will be returned but has yet to be received.Review of device history records found that (b)(4) piece of lot 00149up released for distribution on 5/2/2016 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.Should the product be received, a follow-up medwatch report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a lumbar fixation procedure was performed in saudi arabia, on (b)(6) 2023, utilizing the reform pedicle screw system.The bone was prepared with a 5.5mm tap and while inserting a 6mm reduction screw, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The broken tip piece was removed from the head of the screw and the procedure was completed utilizing another driver readily available in the set.There was no patient injury or delay to the procedure reported.
Event or Problem Description
It was reported that a lumbar fixation procedure was performed on (b)(6), 2023, utilizing the reform pedicle screw system.The bone was prepared with a 5.5mm tap and while inserting a 6mm reduction screw, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The broken tip piece was removed from the head of the screw and the procedure was completed utilizing another driver readily available in the set.There was no patient injury or delay to the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - the driver's t20 drive feature is sheared off.The fracture surface includes a shiny area.A partial fracture may have existed with rubbing of surfaces causing that surface condition.It is believed that a crack had been initiated at some point in the instrument's seven year history which resulted in the observed failure.No corrective actions are recommended.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: 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: 16744994
• Report Number: 3005739886-2023-00012
• Device Sequence Number: 20514985
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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 Model Number: HXX-39-0001
• Device Catalogue Number: HXX-39-0001
• Device Lot Number: 00149UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2016
• 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