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

Model Number	HXX-39-0001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was performed in (b)(6) on (b)(6) 2022, utilizing the reform pedicle screw system.During the placement of the first iliac screw, the doctor noted some resistance of the 80mm screw going into the bone when the tip of the t20, polyaxial driver, reform degen (39-sp-0700) broke.The doctor then attempted to remove the screw in order to place a smaller 70mm one when the tip of a second reform driver with mechanical lock (hxx-39-0001) broke.The procedure was then completed utilizing another driver readily available.There was a ten minute delay to the procedure due to the reported malfunctions.No patient injury was reported.
Additional Manufacturer Narrative
Patient information: unknown.Occupation: other; distributor.Device evaluation: review of device history records found (b)(4) pieces of this lot were released for distribution on 06/26/2017 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for this part number.Without the opportunity to examine the complaint product no conclusions can be drawn as to the cause of the reported malfunction.Should the product be received, a follow-up medwatch report will be submitted following evaluation.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2022-00007).
Additional Manufacturer Narrative
H3 device evaluation - the tips the driver is sheared off.The fracture plane is perpendicular to the driver's longitudinal axis.The fracture surface was examined with the aid of a 5x loop.The complaint notes the surgeon encountered resistance to seating an 80mm long screw and the surgeon attempted to remove the screw when the hxx-39-0001 driver broke.The driver appears to have failed due to torsional overload.The hxx-39-0001 driver appears to have failed during screw insertion.This is evidenced by the clockwise rotation of the hexalobe drive feature relative to the female hexalobe which the hexalobe extended thru.Review of device history records found ten (10) pieces of this lot released for distribution on 6/26/2017 with no deviation or anomalies.Two-year complaint history review (2.17.2020-2.17.2022) found this to be the only report of this nature for this lot.No corrective actions are being recommended since the causes do not appear to be manufacturing related and since the failure rates remain low.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2022-00007-1 / 00008-1).
Event or Problem Description
It was reported that a procedure was performed in puerto rico on (b)(6) 2022, utilizing the reform pedicle screw system.During the placement of the first iliac screw, the doctor noted some resistance of the 80mm screw going into the bone when the tip of the t20, polyaxial driver, reform degen (39-sp-0700) broke.The doctor then attempted to remove the screw in order to place a smaller 70mm one when the tip of a second reform driver with mechanical lock (hxx-39-0001) broke.The procedure was then completed utilizing another driver readily available.There was a ten minute delay to the procedure due to the reported malfunctions.No patient injury was 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: 13720717
• Report Number: 3005739886-2022-00008
• Device Sequence Number: 17208831
• Product Code: HXX
• UDI-Device Identifier: 00840019928809
• UDI-Public: 00840019928809
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 33923MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• 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