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

Model Number 3010-19-008

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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.Event occurred at an unknown date in 2022.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.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 Description

Device report from canada reports an event as follows: it was reported that on an unknown date, the driver in question was found to be unable to engage properly with the navlock interface.There was no reported patient interaction.No further information is available.This report is for a navigation enabled instruments expedium verse driver - shaft.This is report 1 of 1 for (b)(4).

• Brand Name: NAVIGATION ENABLED INSTRUMENTS EXPEDIUM VERSE DRIVER - SHAFT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15236844
• MDR Text Key: 305179849
• Report Number: 1526439-2022-01406
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561622
• UDI-Public: (01)10705034561622
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1