MAUDE Adverse Event Report: SYNTHES GMBH TI VECTRA(TM) PLATE 1 LEVEL/16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.613.016
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.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) ti vectra(tm) plate 1 level/16mm.This is report 1 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.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.
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 one of the four wishbone clip from the ti vectra(tm) plate 1 level/16mm was observed with a edge deformed/bent and protrude from the grove at the screw hole, therefore, interactional issues (will not lock/unlock) are most likely due to this condition.In addition, the rest of the screw holes were examined and no issues were noted.A dimensional inspection for the ti vectra(tm) plate 1 level/16mm was not performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the ti vectra(tm) plate 1 level/16mm would 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.H3, h6: device history record (dhr) review conducted: part number: 04.613.016, lot number: 2518p56, manufacturing site: mezzovico, release to warehouse date: 24 oct 2022.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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: TI VECTRA(TM) PLATE 1 LEVEL/16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17821434
• Report Number: 8030965-2023-12164
• Device Sequence Number: 19443147
• Product Code: KWQ
• UDI-Device Identifier: 10705034737058
• UDI-Public: (01)10705034737058
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K050451
• 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: 04.613.016
• Device Lot Number: 2518P56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• 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
• Date Device Manufactured: 10/24/2022
• 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: 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM; 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM; 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM; 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM
• Patient Age: 76 YR
• Patient Sex: Female