MAUDE Adverse Event Report: SYNTHES GMBH 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.613.616
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h4, h6: 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 or Problem Description
It was reported that on (b)(6) 2023, that during placement of the vectra plate and screws, surgeon found that he could not advance a 4.0 ti cerv slf rtn scr slf-tpng/va 16mm screw beyond the locking mechanism on the plate.Fluoroscopy was used, everything looked acceptable for screw placement and angulation.He removed the screw, and attempted to place a shorter rescue screw 4.5 ti cerv slf rtn scr slf-tpng/va 14mm in its place.That screw would also not pass the locking mechanism.He removed the rescue screw and inspected the plate visually, and saw differences between that screw hole and the others.He elected to remove the entire construct and start new.This led to more 4.0 ti cerv slf rtn scr slf-tpng/va 16mm implants being wasted and are part of this complaint.The surgery was easily completed with a minimal amount of extra time (under 5 minutes).No fragments were generated.There was no patient outcome this report is for one (1) 4.0 ti cerv slf rtn scr slf-tpng/va 16mm this is report 2 of 5 for complaint (b)(4).
Additional 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, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the 4.0 ti cerv slf rtn scr slf-tpng/va 16mm, only was observed normal wear which could have been a result of implantation.A dimensional inspection for the ti vectra(tm) plate 1 level/16mm was not performed as it is not applicable to the complaint condition.A functional test was performed to asses the the interaction of the screw and plate, the devices were able to lock and unlock correctly.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the ti vectra(tm) plate 1 level/16mm would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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.
Additional 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.H3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 17821440
• Report Number: 8030965-2023-12166
• Device Sequence Number: 16754236
• Product Code: KWQ
• UDI-Device Identifier: 10705034737812
• UDI-Public: (01)10705034737812
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.613.616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 10/30/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM; TI VECTRA(TM) PLATE 1 LEVEL/16MM
• Patient Age: 76 YR
• Patient Sex: Female