MAUDE Adverse Event Report: DEPUY SPINE INC NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	3010-19-008
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6)2022 during spinal fusion while attempting to navigate the verse pedicle screw, the holding sleeve would not retain on the driver.This would not allow screw to be navigated.Navigation of screw was discontinued and screw inserted over guidewire.Patient status is unknown.There was no surgical delay.The procedure was successfully completed.This report involves one (1) navigation enabled instruments expedium verse driver - shaft.This is report 1 of 2 for (b)(4).

• Brand Name: NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13560932
• Report Number: 1526439-2022-00248
• Device Sequence Number: 4299418
• Product Code: OLO
• UDI-Device Identifier: 10705034561622
• UDI-Public: (01)10705034561622
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 3010-19-008
• Device Catalogue Number: 301019008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; VERSE SLEEVE
• Patient Age: 64 YR
• Patient Sex: Male