MAUDE Adverse Event Report: DEPUY SPINE INC VERSE POLY DRIVER SHAFT NAV; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number	2997-04-155N
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The reporter is a j&j employee but the address is a customer address 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.If additional information is made available, the investigation will be updated as applicable.510k number: k120867.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 while a rep was making a demonstration prior to surgery for a surgeon with the expedium verse navigation system on (b)(6) 2022, two kinds of shafts were not able to be attached to the driver handle in question.It was finally confirmed that the driver handle in question triggered the event.No patient involvement.This complaint involves one (1) device verse poly driver handle pwr.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D10: date of concomitant therapy is (b)(6) 2022.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.E3: reporter is not a synthes employee.

• Brand Name: VERSE POLY DRIVER SHAFT NAV
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14253499
• Report Number: 1526439-2022-00645
• Device Sequence Number: 20013336
• Product Code: OLO
• UDI-Device Identifier: 10705034501444
• UDI-Public: 10705034501444
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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: 2997-04-155N
• Device Catalogue Number: 299704155N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 06/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/03/2022; 06/30/2022
• 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: VERSE POLY DRIVER SHAFT PWR
• Patient Sex: Unknown