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

Model Number	HXX-39-0001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; inventory manager, distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00034).
Event or Problem Description
It was reported that a revision plif was performed, on (b)(6) 2021, utilizing the reform pedicle screw system.During the procedure, a reform modular 6.5 x 40mm polyaxial bone screw (39-ms-6540) was removed, the hole was then tapped with the 65mm& 75mm taps and upon insertion of a reduction polyaxial screw assembly - æ7.5mm x 50mm (39-rp-7550), driving with power, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The screw was helicoptered out and replaced.Subsequently, another level was prepped using the 65mm, 75mm & 85mm taps in sequence and upon insertion of a reform 8.5 x 110mm polyaxial pedicle screw (39-pa-8511), the tip of a second reform driver with mechanical lock (hxx-39-0001) broke.This failure occurred before the screw was fully seated.The screw was helicoptered out and replaced with a reform 8.5 x 100mm polyaxial pedicle screw (39-pa-8500), utilizing a driver that was readily available in another reform set.There was no patient injury, but there was a delay of five (5) minutes because of the reported malfunctions.Initial implantation was two-years ago.Revision was required to add more stability and extend the construct.
Additional Manufacturer Narrative
H3 device evaluation - both drivers were examined by eye and with the aid of a 5x loop.The fractured surface of the 33936mm component is not fully a flat planer break.There is a flat planer area as well as a secondary non-planer area that is believed to be the final breakage area.It is not clear if the breakage was solely due to this usage or if prior usage resulted in a fracture that manifested itself in this procedure.Review of device history recordsfound thirty (30) pieces of this lot were released for distribution on 8/31/2017 with no deviation or anomalies.Complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00034-1 / 00035-1).
Event or Problem Description
It was reported that a revision plif was performed, on (b)(6) 2021, utilizing the reform pedicle screw system.During the procedure, a reform modular 6.5 x 40mm polyaxial bone screw (39-ms-6540) was removed, the hole was then tapped with the 65mm& 75mm taps and upon insertion of a reduction polyaxial screw assembly - æ7.5mm x 50mm (39-rp-7550), driving with power, the tip of the reform driver with mechanical lock (hxx-39-0001) broke.The screw was helicoptered out and replaced.Subsequently, another level was prepped using the 65mm, 75mm & 85mm taps in sequence and upon insertion of a reform 8.5 x 110mm polyaxial pedicle screw (39-pa-8511), the tip of a second reform driver with mechanical lock (hxx-39-0001) broke.This failure occurred before the screw was fully seated.The screw was helicoptered out and replaced with a reform 8.5 x 100mm polyaxial pedicle screw (39-pa-8500), utilizing a driver that was readily available in another reform set.There was no patient injury, but there was a delay of five (5) minutes because of the reported malfunctions.Initial implantation was two-years ago.Revision was required to add more stability and extend the construct.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SXCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11870884
• Report Number: 3005739886-2021-00035
• Device Sequence Number: 1128244
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/28/2021

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: 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: 04/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/21/2021
• 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: Required Intervention