MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 NAV DRIVER - SHAFT T20; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 3010-19-003

Device Problem Break (1069)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, during spinal fusion surgery the surgeon was performing a posterior thoracic spine fusion with expedium poly screws using medtronic stealth navigation.While using the expedium navlock driver and inserting the screw, the tip of the driver broke off in the screw.The surgeon was able to retrieve the broken part of the driver tip from the screw and used another driver to complete the surgery.Procedure was successfully completed with five (5) minutes of surgical delay.This report is for one (1) 5.5 nav driver - shaft t20.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.H6 - codes updated to imdrf codes.Visual inspection: the complaint device 5.5 nav driver - shaft t20 (product code: 301019003, lot number: mi102001) was returned to cq west chester for investigation.The tip of the driver had broken off and broken piece was not returned.No other issues were identified.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Conclusion: the tip of the navigation driver had broken off during use.This might have been due to the excessive pressure applied.But, a definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - a review of the receiving inspection (ri) for 5.5 nav driver - shaft t20 was conducted identifying that lot number mi102001 was released in a single batch.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review - the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

• Brand Name: 5.5 NAV DRIVER - SHAFT T20
• Type of Device: 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: 13053258
• MDR Text Key: 285619638
• Report Number: 1526439-2021-02602
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034561387
• UDI-Public: (01)10705034561387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3010-19-003
• Device Catalogue Number: 301019003
• Device Lot Number: MI102001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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
• Treatment: SI POLYAXL SCREW 6 X 45MM