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	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure on (b)(6) 2022, to address a broken reform pedicle screw, attributed to non-fusion.The original implantation date was not provided.The existing construct was removed and upon attempted insertion of a of a reform 10.5 x 50mm polyaxial pedicle screw (39-pa-1050) in a newly prepared pedicle, the tip of the reform polyaxial driver (hxx-39-0001) broke off in the head of the screw.The screw was then removed and successfully replaced with another screw using a second driver in the set.Subsequently, while implanting another reform 10.5 x 50mm polyaxial pedicle screw (39-pa-1050) the screw was 85% seated when the head of the screw sheared off at the neck between the screw head and threaded shaft.The threaded shaft was left in the patient's bone and the pedicle was left un-fixated.The construct was successfully completed with no harm to the patient.There was a delay of one hour because of the reported malfunctions.
Additional Manufacturer Narrative
Patient information - unknown.Lot number - unknown.Initial reporter occupation - other; sales representative.Device manufacture date - unknown.Device evaluation - although information received indicates that the product is available for evaluation, it has not been received so product evaluation is not possible at this time.Without lot identification, manufacturing history review and lot specific complaint history review were not possible.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.Without the ability to examine the product, no conclusions can be drawn as to the cause of the reported breakage.Should the product be received, a follow-up medwatch report will be submitted.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2022-00011 / 00013).
Additional Manufacturer Narrative
This report is for the t20 polyaxial driver reform pedicle screw system that the tip broke off while implanting a screw.Product was received on 4/28/2022 providing corrected information.The following information has been corrected: b1 adverse event or product problem, b5 description of event or problem, d4 part number, lot number & unique device identifier, d10 device availability & h3 device evaluated by manufacturer.Upon completion of device evaluation, a follow-up report will be submitted to provide investigation results.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2022-00011-1 / 00013-1).
Event or Problem Description
It was reported that the patient underwent a revision procedure on (b)(6) 2022 to address a broken reform pedicle screw, attributed to non-fusion.The original implantation date was not provided.The existing construct was removed and upon attempted insertion of a of a reform ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) in a newly prepared pedicle, the tip of the t20 polyaxial driver reform pedicle screw system (39-sp-0730) broke off in the head of the screw.The screw was then removed and successfully replaced with another screw usinig a second driver in the set.Subsequently, while implanting another ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) the screw was 85% seated when the head of the screw sheared off at the neck between the screw head and threaded shaft.The threaded shaft was left in the patient's bone and the pedicle was left un-fixated.The construct was successfully completed with no harm to the patient.There was a delay of one hour because of the reported malfunctions.
Additional Manufacturer Narrative
H3 device evaluation - the broken driver was examined by eye and with the aid of a 5x loop.The driver fracture is normal to its longitudinal axis.The failure mode appears to be in agreement with a ductile torsional overload.Review of device history records found ten (10) pieces of this lot released for distribution on 8/22/2018 with no deviation or anomalies.Complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended at this time.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2022-00011-1 / 00013-2).
Event or Problem Description
It was reported that the patient underwent a revision procedure on (b)(6) 2022 to address a broken reform pedicle screw, attributed to non-fusion.The original implantation date was not provided.The existing construct was removed and upon attempted insertion of a of a reform ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) in a newly prepared pedicle, the tip of the t20 polyaxial driver reform pedicle screw system (39-sp-0730) broke off in the head of the screw.The screw was then removed and successfully replaced with another screw usinig a second driver in the set.Subsequently, while implanting another ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) the screw was 85% seated when the head of the screw sheared off at the neck between the screw head and threaded shaft.The threaded shaft was left in the patient's bone and the pedicle was left un-fixated.The construct was successfully completed with no harm to the patient.There was a delay of one hour because of the reported malfunctions.

• 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: 14138140
• Report Number: 3005739886-2022-00012
• Device Sequence Number: 4728251
• Product Code: HXX
• UDI-Device Identifier: 00815362022016
• UDI-Public: 00815362022016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HXX-39-0001
• Device Catalogue Number: 39-SP-0730
• Device Lot Number: 18817PS
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022; 03/24/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/11/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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