MAUDE Adverse Event Report: SYNTHES GMBH INNER SHAFT FOR EXTRACTION SCREWDRIVER

Model Number 03.613.004

Device Problems Activation, Positioning or Separation Problem (2906); Compatibility Problem (2960); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2022

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.Patient identifier: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

It was reported that during an anterior cervical fusion procedure on (b)(6) 2022, the surgeon decided to reposition one of the screws.The removal screwdriver was assembled because the regular screwdriver was not able to remove the screw.The removal driver was used to remove the desired screw successfully.Once all of the screws were placed, an x-ray was taken for what was anticipated as a final picture.Although all of the screws were acceptable, the surgeon wanted to change the trajectory of one of the top screws.The regular screwdriver was tried, but it was unsuccessful at taking out the desired screw.The removal driver was used, but the surgeon stated that the driver was just spinning inside the screw and was not seating down properly.Upon inspection of the removal driver, it was noticed that the inner shaft that threads into the screw was not showing.The screw was then examined, and it was noted that the threaded portion had broken off inside the screw.The broken screw set was opened in hopes of finding the correct conical extraction bit.One bit was attempted, but the cannulation was not big enough to fit the broken piece through, therefore it was unable to be used.The surgeon figured that the correct bit that would fit was missing from the set.The surgeon made the call to leave the broken piece in the screw and close the incision.There was no surgical delay.The procedure was completed successfully.This report involves one inner shaft for extraction screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: INNER SHAFT FOR EXTRACTION SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16033305
• MDR Text Key: 305981949
• Report Number: 8030965-2022-11437
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.613.004
• Device Catalogue Number: 03.613.004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/18/2023
• 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: UNK - DRILL BITS: SPINE; UNK - LOCKING/SET SCREWS; UNK - SCREWS: SPINE-US
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male