MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL OBT_BUTTON_4.0,167CW_MITEK; ACCESSORIES, ARTHROSCOPIC

Catalog Number	242258
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the healthcare professional that on 11/14/2023, it was observed that the hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) device was cloudy and the obturator with button top for 5.9mm sheath 167mm (mitek lock) device was bent.It was unknown whether the event occurred during surgery.However, it was reported that there was no patient involvement.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual inspections revealed that the surface of the device and the tip shows wear marks and deformed condition indicating that heavily use.The obturator was tried to disassemble and assembled of the dual sheath, there was a resistance, and it was difficult to dissemble; the condition of the shaft might have contributed to this issue.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Based on the visual inspection of the device, this complaint can be confirmed.The possible root cause for the reported failure can be related when the device might have been dropped or device was tapped against a hard surface accidentally, as well as rough use by the user; moreover, this failure reported can be related to the wear and tear of the device.As per ifu, do not use a damaged or defective endoscope.Inspect the endoscope prior to each examination or procedure and before sterilization based on the instructions in this document; it is important to check the shaft for bending, scratches, dents, corrosion, pitting, or other surface irregularities.Do not hold the endoscope by its shaft; this may cause damage and do not bend the endoscope or subject the endoscope to impact.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: OBT_BUTTON_4.0,167CW_MITEK
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18220478
• Report Number: 1221934-2023-04295
• Device Sequence Number: 5788165
• Product Code: NBH
• UDI-Device Identifier: 10886705029174
• UDI-Public: 10886705029174
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242258
• Device Lot Number: 1530729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/12/2023; 01/04/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/18/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown