MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SHE_2RSTCK_5.9,30,167CW_ MITEK; ACCESSORIES, ARTHROSCOPIC

Catalog Number 242025

Device Problems Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 01/23/2024

Event Type  malfunction  

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.H10 additional narrative: (b)(4) d4: the expiration date is currently unavailable.E3: reporter is a j&j sales representative.Investigation summary the device associated with this report was returned to depuy synthes mitek for evaluation.Upon visual inspection revealed that the she_2rstck_5.9,30,167cw_ mitek shows wear mark indicating it was heavily used in the field.The device was found with scratches in distal part and near the tip.A functional test was performed, the obturator was assembled in the sheath; as a result, a resistance was felt when trying to assemble and disassemble.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the she_2rstck_5.9,30,167cw_ mitek would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

Event Description

It was reported by sales rep that before an unknown procedure on (b)(6) 2024, it was observed that dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock) was bent.During in-house engineering evaluation, a functional test was performed with the obturator assembled in the sheath which resulted in a resistance when trying to assemble and disassemble.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: SHE_2RSTCK_5.9,30,167CW_ MITEK
• 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: 18751262
• MDR Text Key: 336401228
• Report Number: 1221934-2024-00543
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 242025
• Device Lot Number: 1486931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1