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

Model Number	39-SP-0730
Health Effect - Clinical Code	Insufficient Information (4580)
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.Date of event - unknown.Occupation - other; sales representative.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 procedure was performed on an unknown date, utilizing the reform pedicle screw system.While attempting to insert a reform pedicle screw ha coated, the tip of the driver broke.The broken tip was left in the head of the screw, implanted in the patient.There was no delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver was examined with the aid of a 5x loop.The tip has been sheared off with the fracture plane normal to the driver's longitudinal axis.It cannot be ascertained if the failure was solely due to the loading condition applied during this procedure or if prior loading may have initiated a crack the subsequently manifested in the observed failure.The likely cause for the failure is high torque application.Review of device history records found a total of six (6) six pieces of lot 16999ps-r released for distribution in march of 2018 and may of 2020 with no deviation or anomalies.Two-year complaint history review (6.14.2019-6.14-2021) found this to be the only report of this nature for the reported lot.Further review did not identify a trend for reports of this nature for the reported part number.No corrective actions are being recommended at this time.
Event or Problem Description
It was reported that a procedure was performed on an unknown date, utilizing the reform pedicle screw system.While attempting to insert a reform pedicle screw ha coated, the tip of the driver broke.The broken tip was left in the head of the screw, implanted in the patient.There was no delay to the procedure.

• 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: 12150550
• Report Number: 3005739886-2021-00041
• Device Sequence Number: 20003275
• Product Code: HXX
• UDI-Device Identifier: 00815362022016
• UDI-Public: 00815362022016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/14/2021

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: 39-SP-0730
• Device Catalogue Number: 39-SP-0730
• Device Lot Number: 16999PS-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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: Other