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

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 1 of 2 mdrs filed for the same event (reference 3005739886-2021- 00035).
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
Device evaluation - both drivers were examined by eye and with the aid of a 5x loop.The 00355up-r is a flat planer surface that is normal to the driver's longitudinal axis that is indicative of a torsional overload failure.It is unclear if prior usage loading over its 4 plus year usage may have contributed to the subsequent failure.Review of device history records found twenty (b)(4) pieces of this lot were released for distribution (b)(6)2016 with no deviation or anomalies.Complaint history review did not identify a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.This report is number 1 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: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11870891
• Report Number: 3005739886-2021-00034
• Device Sequence Number: 19114637
• 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: 00355UP-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• 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