MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 CAN/RED SCRW 3.5X12; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	102035312S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
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.Additional narrative: d2: additional procode: kwp d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.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.
Event or Problem Description
It was reported that patient underwent a c5-c6 posterior fusion using the symphony posterior cervical system.The surgeon opted to use the long tab screws.The procedure went smoothly, until part of the final step where the tabs have to be removed.The symphony tab breaker was available, but there was huge resistance to the tab snapping.As the surgeon was applying force to the tab breaker the whole construct and neck were visibly twisting with his movement.Surgeon swapped to using a pair of nibblers.The tab still were resistant to snapping.The tabs were removed by using a rod holder on the rod in situ to stabilise while force was applied to snap the tabs.It wasn¿t ideal and the rod was exposed, and swollen, so there was a huge risk to further damage.There was no reported patient complications.Procedure was completed with no delay.This report is for a 4.0 can/red scrw 3.5x12.This is report 2 of 4 for (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.H11 additional narrative: h4 device history a manufacturing record evaluation was performed for the finished device product code # 102035312s, lot # 368147.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 27-apr-2023.Manufacturing site:jabil le locle.Expiry date:31-mar-2028.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 CAN/RED SCRW 3.5X12
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19575094
• Report Number: 1526439-2024-01692
• Device Sequence Number: 8524888
• Product Code: NKG
• UDI-Device Identifier: 10705034527796
• UDI-Public: (01)10705034527796(11)230427(17)280331(10)368147
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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

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: 102035312S
• Device Lot Number: 368147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female