MAUDE Adverse Event Report: SYNTHES GMBH SYNFIX® EVOLUTION SCREW/20MM STERILE-2PK; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	04.835.220.02S
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in chile as follows: during the surgery, at the time of placement of the cage, the screws could not be placed.It was attempted to place the 4 screws, but all of them rotated falsely, it was not possible to make the final torque.The cage was left without screws in the patient.The surgery was delayed due to the reported event for 60 minutes.This report is for one (1) synfix® evolution screw/20mm sterile-2pk.This is report 4 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is (b)(6) 2024 h3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.Part number: 04.835.220.02s, lot number: 51p0776, manufacturing site: mezzovico, release to warehouse date: 12 may 2020, expiration date: 01 may 2030.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFIX® EVOLUTION SCREW/20MM STERILE-2PK
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18581220
• Report Number: 8030965-2024-01361
• Device Sequence Number: 20883847
• Product Code: OVD
• UDI-Device Identifier: 20705034816149
• UDI-Public: (01)20705034816149
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K150673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 04.835.220.02S
• Device Lot Number: 51P0776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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: SYNFIX EVOLUTION LOCK SCR 25 2U; SYNFIX EVOLUTION LOCK SCR 25 2U; SYNFIX EVOLUTION SPACER SM H10.5 10°; SYNFIX® EVOLUTION SCREW/20MM STERILE
• Patient Sex: Male