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

Model Number	HXX-39-0001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
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.
Event or Problem Description
Information received from the distributor indicates that a procedure was performed by on (b)(6) 2019, utilizing the reform pedicle screw system.Upon attempted insertion of a screw the tip of a reform driver with mechanical lock (hxx-39-0001) broke.The tip was removed and the procedure was completed utilizing another driver readily available in the set.There was no patient injury or delay to the procedure.
Event or Problem Description
Information received from the distributor indicates that a procedure was performed on (b)(6) 2019, utilizing the reform pedicle screw system.Upon attempted insertion of a screw the tip of a reform driver with mechanical lock (hxx-39-0001) broke.The tip was removed and the procedure was completed utilizing another driver readily available in the set.There was no patient injury or delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the returned driver was visually examined with and without the aid of a 5x loop.The driver tip is fractured perpendicular to the longitudinal axis.It cannot be ascertained if this fracture was solely the result of the loading condition that occurred in this procedure or if a prior loading condition had initiated a crack that manifested itself during this procedure.Review of device history records found thirty (30) pieces of this lot were released for distribution on 8/31/2017 with no deviation or anomalies.Two-year complaint history review found one (1) previous report of this nature for this lot.No corrective actions are being recommended since the failure does not appear to manufacturing related, the cause for the failure remains unknown, and since design changes to like devices have been rolled into use to improve device resistance to breakage.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9565481
• Report Number: 3005739886-2020-00001
• Device Sequence Number: 2860724
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/11/2019

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: 33936MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1