MAUDE Adverse Event Report: DEPUY SPINE INC UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279734000N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2022

Event Type  Injury  

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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j employee.A review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm4735202 was released in one batch.(b)(4).Supplier: depuy : (b)(4).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.Product was not returned.Based on the information available, it has been determined that no corrective and 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

It was reported that on (b)(6) 2022, the navigated expedium screw driver tip broke off while inserting a screw into the pedicle.The pedicle screw was inserted correctly, and the tip cold welded to the drive mechanism of the expedium screw, where the screwdriver tip meets the actual expedium screw.The tip could not be removed, and the rod and set screw were final tightened effectively.The procedure was completed successfully with no delay.This report involves one universal navigation expedium spine system quick connect poly driver 5.5.This is report 1 of 1 for (b)(4).

• Brand Name: UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5
• Type of Device: ORTHOPEDIC 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: 15804439
• MDR Text Key: 303714604
• Report Number: 1526439-2022-01963
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: 10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM4735202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2017
• 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: UNK - SCREWS: EXPEDIUM.
• Patient Outcome(s): Required Intervention