MAUDE Adverse Event Report: CLARIANCE SAS IDYS-ALIF; IDYS-ALIF PLATE H14MM

Model Number	24430014-S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3 screws were used normally without problem.The surgeon was unable to properly lock the fourth screw into the plate.The surgeon opted to not swap out the plate and just used 3 screws.Accordingly, this event is reportable as a malfunction.
Event or Problem Description
Surgeon couldn't get screw to lock into plate during implantation.Upon inspection, the locking ring looked fine and not damaged at all to surgeon.The surgeon opted to not swap out the plate and just use three screws.He cleared the plate/screw interface area of any debris and the screw still wouldn't lock.At this point, it was adjudged by the surgeon to proceed with three screws.
Event or Problem Description
Surgeon couldn't get screw to lock into plate during implantation.Upon inspection, the locking ring looked fine and not damaged at all to surgeon.The surgeon opted to not swap out the plate and just use three screws.He cleared the plate/screw interface area of any debris and the screw still wouldn't lock.At this point, it was adjudged by the surgeon to proceed with three screws.
Additional Manufacturer Narrative
3 screws were used normally without problem.The surgeon was unable to properly lock the fourth screw into the plate.The surgeon opted to not swap out the plate and just used 3 screws.Accordingly, this event is reportable as a malfunction.(b)(6) 2024 - the plate used was conforming to clariance's specification (control report and raw material certificates).Analysis on the parts was not possible, as it was not explanted from the patient.Clariance's team was able to reproduce the event where the sleeve was not firmly tightened while the screw was fully inserted.Same difficulty with the screw removal was observed.However, with the use of the provided counter torque, and t20 tightening key, untightening of the screw was made possible without issue.Two hypotheses were made, one regarding the condition in which the surgeon tried to remove the device, with lack of visibility and presence of tissues conflicting with the use of the counter torque, and one with the method used.

• Brand Name: IDYS-ALIF
• Common Device Name: IDYS-ALIF PLATE H14MM
• Manufacturer (Section D): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer (Section G): CLARIANCE SAS; 18 rue robespierre; beaurains, 62217 ; FR 62217
• Manufacturer Contact: magalie hennequin ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 18155303
• Report Number: 3009962553-2023-00004
• Device Sequence Number: 7992418
• Product Code: OVD
• UDI-Device Identifier: 03700780627127
• UDI-Public: (01)03700780627127(17)270501(10)N339X-N317Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 24430014-S
• Device Catalogue Number: 24430014-S
• Device Lot Number: N339X-N317Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown