MAUDE Adverse Event Report: SYNTHES GMBH 6.2MM TI SCHANZ SCREW WITH DUAL CORE 35MM THREAD/180MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 496.721

Device Problem Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Device was implanted for approximately one year.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that on an unknown date, one of the four uss frx screws (6.2mm diam in patient's left l2) had broken.By the time the surgeon was ready to remove all implants as standard procedure, the system in total had done its job, and the surgeon stated he was happy to leave the broken thread portion where it was rather than try to dig for it.Procedure was completed successfully.There was no patient consequence.This report is for a 6.2mm titanium (ti) schanz screw.This is report 1 of 1 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.H3, h4, h6- the device was not returned.A photo-investigation was performed upon inspecting all the images provided under attachment section, the transpedschanzscr ø6.2 l180/35 tan dblue screw was observed to be broken.The root cause for the reported event cannot be determined from the available information.Manufacturing record evaluation could not be performed as lot number information was not available.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint condition can be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review could not be performed as lot number information was not available.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: 6.2MM TI SCHANZ SCREW WITH DUAL CORE 35MM THREAD/180MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12315353
• MDR Text Key: 266371825
• Report Number: 8030965-2021-06616
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819112162
• UDI-Public: (01)07611819112162
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 496.721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention