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	07/14/2021
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.Lot number - unknown.Occupation - other; distributor.Device evaluation - although the information provided indicates that the product is available for evaluation, it has yet been received by the manufacturer.At this time, no conclusions can be drawn.Should the product be received, a follow-up medwatch report will be filed upon completion of the investigation.Device manufacture date - unknown.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2021, using the reform pedicle screw system.When the doctor was attempting to back out a screw that he had just implanted, the tip of the reform driver with mechanical lock (hxx-39-0001) broke off.The tip was unable to be removed and remains implanted in the head of the screw.The second driver, readily available in the set, was used to complete the procedure with no delay.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2021, using the reform pedicle screw system.When the doctor was attempting to back out a screw that he had just implanted, the tip of the reform driver with mechanical lock (hxx-39-0001) broke off.The tip was unable to be removed and remains implanted in the head of the screw.The second driver, readily available in the set, was used to complete the procedure with no delay.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is missing.The fracture is in a plane that is normal to the driver's longitudinal axis which is consistent with a torsional overload failure.High torque application is the suspected cause for the failure but crack initiation may have been initiated during prior usage.Review of device history records found (b)(4) pieces of this lot released for distribution 12/13/2016 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for complaints of this nature for this part number.No corrective actions are recommended at this time.

• 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: 12297291
• Report Number: 3005739886-2021-00044
• Device Sequence Number: 3839732
• 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): 07/14/2021

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: HXX-39-0001
• Device Catalogue Number: HXX-39-0001
• Device Lot Number: 00355UP-R
• 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: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown