MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK); ACCESSORIES, ARTHROSCOPIC

Catalog Number 242258

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported by the affiliate in japan that before sterilization, it was observed that the obturator with button top for 5.9mm sheath 167mm (mitek lock) device was deformed.According to the report, when the surgeon tried to insert the obturator in question into the sheathe before sterilization, there was strong resistance and it did not go in.There was no procedure nor patient involvement reported.No additional information was provided.

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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.E3: reporter is a j&j employee.H4: the device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H10 additional narrative: investigation summary the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the device had wear marks indicating it was heavily used in the field.The device was found with scratches in shaft.The device does not show any structural anomalies.The functional test cannot be performed due to the sheath was not received along with the device for evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the visual inspection of the device, this complaint cannot be confirmed.A root cause for the issue experienced by the customer cannot be established.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: OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK)
• Type of Device: 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: 17452473
• MDR Text Key: 320330884
• Report Number: 1221934-2023-02936
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029174
• UDI-Public: 10886705029174
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 242258
• Device Lot Number: 1596128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/11/2023; 08/15/2023
• Supplement Dates FDA Received: 08/11/2023; 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1