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

Model Number	39-SP-0700
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Other serious (important medical events): this is being reported as a serious injury (retained foreign object) due to the fractured tip of the driver being left in the head of the polyaxial screw implanted in the patient.It is important to note that once the rod implant is seated and locked into the tulip of the polyaxial screw, the fractured tip is prevented from dislodging as long as the rod remains firmly locked in place.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
It was reported that a revision procedure was performed to extend and existing construct on (b)(6) 2020, utilizing the reform pedicle screw system.After tapping the bone using the 6.5mm & 7.5mm taps a 7.5 x 55mm reform pedicle screw was being placed when the tip of the polyaxial driver (39-sp-0700) broke.The screw was fully seated and the broken tip of the driver was left in the head of the screw.The procedure was successfully completed utilizing the second driver readily available in the set with no delay.
Event or Problem Description
It was reported that a revision procedure was performed to extend and existing construct on (b)(6) 2020, utilizing the reform pedicle screw system.After tapping the bone using the 6.5mm & 7.5mm taps a 7.5 x 55mm reform pedicle screw was being placed when the tip of the polyaxial driver (39-sp-0700) broke.The screw was fully seated and the broken tip of the driver was left in the head of the screw.The procedure was successfully completed utilizing the second driver readily available in the set with no delay.
Additional Manufacturer Narrative
H3 device evaluation - the driver was examined by eye as well as with the aid of a 5x loop.The tip is fractured.The fracture is perpendicular to the driver's longitudinal axis.It cannot be ascertained if the fracture was solely due to the forces needed to seat the screw or if it was a combination of prior crack initiation and the applied loading condition.Review of device history records found (b)(4) pieces of lot 3267mm were released for distribution on 11/25/2014 with no deviation or anomalies.Two-year complaint history review (2.14.2018-2.14.2020) found this to be the only 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: 9812097
• Report Number: 3005739886-2020-00010
• Device Sequence Number: 10914909
• Product Code: HXX
• UDI-Device Identifier: 00840019928731
• UDI-Public: 00840019928731
• 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): 02/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 39-SP-0700
• Device Catalogue Number: 39-SP-0700
• Device Lot Number: 3267MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other