MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK); RIGID ENDOSCOPE OBTURATOR

Model Number 242258

Device Problems Use of Device Problem (1670); Mechanical Jam (2983)

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

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.Udi: (b)(4).The complaint device was received for evaluation.Upon visual inspection, it was found that the obturator is jammed inside the sheath, the end of the sheath shaft is deformed.A manufacturing record evaluation was performed for the finished device 1665341 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for this issue can be attributed to procedural variables, such handling of the device or product interaction during procedure, since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to damages on the sheath, therefore, the obturator can not be fully inserted, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

This is report 2 of 2 for (b)(4).It was reported by the affiliate in (b)(6) that preoperatively to an unknown surgery on an unknown date, it was observed that the obturator with button top for 5.9mm sheath 167mm (mitek lock) device did not work properly.During in-house engineering evaluation, it was determined that obturator was jammed inside the sheath.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.

• Brand Name: OBTURATOR WITH BUTTON TOP FOR 5.9MM SHEATH 167MM (MITEK LOCK)
• Type of Device: RIGID ENDOSCOPE OBTURATOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• 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: 14700269
• MDR Text Key: 302507718
• Report Number: 1221934-2022-01764
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029174
• UDI-Public: 10886705029174
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

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 Model Number: 242258
• Device Catalogue Number: 242258
• Device Lot Number: 1665341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1