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	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Initial reporter occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that the tip of the retention bone-screw driver (39-sp-0601) broke during a removal case performed on (b)(6) 2021.No additional details were provided.There was no patient injury or significant delay to the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is missing.The fracture surface was examined by eye and with the aid of a 5x loop.The fracture is severely skewed relative to the driver's longitudinal axis, multiple fracture planes are present, and the remnant of the outer lobe is rotated in a clockwise direction which is agreement with implant removal.Based upon the fracture topography it is believed that high bending moments in conjunction with torsional loading are the cause for the failure.Review of device history records found fourteen (14) pieces of lot 14810ps released for distribution on 8/25/2017 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.
Event or Problem Description
It was reported that the tip of the retention bone-screw driver (39-sp-0601) broke during a removal case performed on (b)(6) 2021.No additional details were provided.There was no patient injury or significant delay to the procedure reported.

• 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: 12433599
• Report Number: 3005739886-2021-00049
• Device Sequence Number: 14539589
• Product Code: HXX
• UDI-Device Identifier: 00840019928700
• UDI-Public: 00840019928700
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 14810PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• 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: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• 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