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

Model Number	X022-0240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the grip set screw on top of the wing lock pedicle screwdriver broke during surgery.There were no reported patient complications.The procedure was successfully completed with an alternate driver from the surgical set.A visual assessment of the returned pedicle screwdriver showed an instrument with repeated use.The square thread detail at the distal end of the driver was fully intact.The grip set screw was broken from the instrument and not returned.A functionality assessment could not be performed due to the grip set screw being broken from the instrument.It is unclear how the grip set screw was broken from the instrument during a surgical procedure.It may be possible that the grip set screw could break if it were rotated with excessive force.The grip set screw secures the hex shaft and sleeve to rotate together.If the hex shaft and sleeve were rotating independently of one another, excessive rotational force could be applied to the grip set screw to secure the components, resulting in it breaking from the instrument.It may also be possible that the grip set screw could be broken if it were inadvertently impacted during the surgery.A dhr review was performed.The device met all required specifications prior to being released to distribution on 01/18/2013.
Event or Problem Description
The complainant reported that the grip set screw on top of the wing lock pedicle screwdriver broke during surgery.There were no reported patient complications.The procedure was successfully completed with an alternate driver from the surgical set.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade 59714
• MDR Report Key: 8864508
• Report Number: 3005031160-2019-00036
• Device Sequence Number: 19352529
• Product Code: HXX
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 026792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/06/2019
• 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