MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME NAV SHAFT ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750131N
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a nuvasive lateral procedure, the surgeon reported that the navigated viper prime driver did not properly function.The articulating part of the driver was difficult to rotate.The navigated viper prime driver could not be disassembled.The procedure was delayed by one hour.The procedure was successfully completed.This report is for one (1) viper prime nav shaft assy.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER PRIME NAV SHAFT ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12239626
• Report Number: 1526439-2021-01545
• Device Sequence Number: 3531571
• Product Code: OLO
• UDI-Device Identifier: 10705034507781
• UDI-Public: (01)10705034507781
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 286750131N
• Device Catalogue Number: 286750131N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1