MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0240
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant stated that the threads on a pedicle screwdriver were wearing away.The damage was reported to have happened while trying to disengage a pedicle screw from the screwdriver after implantation.There were no known patient complications.The screwdriver was returned for assessment; it showed signs of repeated use, and the complainant's claim was confirmed that the threads were damaged.The surgical technique guide provides guidance on how to load and disengage pedicle screws from the driver.There is also a warning included to prevent damage to the driver when being disengaged from an implanted pedicle screw.In step 6: pedicle screwdriver it states, "if the ratcheting screwdriver handle (attached to the proximal end of the pedicle screwdriver at this step in the technique) is not placed in the neutral, non-ratcheting position for screw disengagement, the (pedicle screw) driver may be difficult to disengage from the screw." there is also a note included in this step which states, "if the user turns the driver with high torque force without placing the handle in the neutral position, this could cause considerable damage to the threads including causing them to break off completely." it is possible that the damage to the returned drivers was a result of not placing the ratcheting handle in the neutral position for screw disengagement.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.
Event or Problem Description
The complainant stated that the threads on a pedicle screwdriver were wearing away.The damage was reported to have happened while trying to disengage a pedicle screw from the screwdriver after implantation.There were no known patient complications.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8327295
• Report Number: 3005031160-2019-00008
• Device Sequence Number: 206211
• Product Code: HXX
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: X022-0240
• Device Lot Number: 6336-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/11/2019
• 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