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 Problem Break (1069)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in ireland as follows: it was reported that on (b)(6) 2022, the surgeon was using the igs screw driver in combination with the stealth adaptor and navigation at time of the incident.He used a 10x100mm expedium screw in the s2ai region and the torque force broke the tip of the screwdriver in the screw shaft, which meant that there was no way to re-engage another screw driver to turn the screw all the way down.The surgeon calibrated another screwdriver as there were two on the set to put in a 10x90mm screw on the same level but on the opposite side, and the same thing happened.Luckily the screws were far enough down so that the surgeon could accept the post-op x-ray, and the outcome for the patient was good.There was a slight delay in surgery.No further information is available.This report involves one universal navigation expedium spine system quick connect poly driver 5.5.This is report 1 of 2 for (b)(4).

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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.H6 a review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm4618101 was released in one batch.Batch 1: lot units were released on 09 aug 2016 with no discrepancies; supplier: (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.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.

• 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: 15925792
• MDR Text Key: 308025612
• Report Number: 1526439-2022-02080
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM4618101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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: 5.5 VIPER UNIV POLY DRIVER.; EXP TI POLY SCREW 10MMX100MM.; EXP TI POLY SCREW 10MMX90MM.