MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN SCREWDRIVERS

Device Problem Device-Device Incompatibility (2919)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/02/2022

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.This report is for an unknown screwdriver/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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 synthes reports an event in japan as follows: it was reported that a patient underwent a posterior cervical fusion (c3) for the vertical subluxation on (b)(6) 2022.After insertion of the lateral screw at right c3, the surgeon tried to change direction of the screwhead with the adjuster, but the screwhead did not move.There was a possibility that the screw hit the bone because the screw insertion was too deep.Although the surgeon floated the screw slightly in reverse, the screwhead did not move.When the surgeon turned the screw backwards with the adjuster, the screw started to come out.After removing the screw, the surgeon checked the screw, and the screwhead was stuck and did not move at all.The screw hole was widened because of removing the screw with the adjuster, so a larger size screw was inserted.The surgery was completed successfully within a thirty (30) minute delay.Inadequate installation of the screwdriver was suspected.The screwdriver tip might have not been firmly attached in the screw core.The patient status was reported as stable.This report is for an unknown screwdriver.This is report 2 of 2 for (b)(4).

• Brand Name: UNKNOWN SCREWDRIVERS
• Type of Device: SCREWDRIVERS
• 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: 15962386
• MDR Text Key: 305327976
• Report Number: 1526439-2022-02129
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/12/2022
• 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
• Treatment: 4.0 PLY SCRW 3.5X14.; UNKNOWN ADJUSTER.
• Patient Outcome(s): Required Intervention