MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	214116
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
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.H11: additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition.The rubber bung was found damaged.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the clearcannula-threaded 7.0mmx75mm 5pk -st would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; excessive force being applied to pass instruments through the cannula which would cause damage to the silicone bung; as per ifu; care should be exercised to avoid puncturing the rubber seals when inserting the obturator or any other instrument through the dam.If the seals become damaged, discontinue use of the cannula.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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 or Problem Description
It was reported that during a shoulder arthroscopy procedure, it was discovered that the clearcannula-threaded 7.0mmx75mm 5pk -st device had a leak in the sealing hole of the threaded cannula.During in-house engineering evaluation, it was determined that the device was fractured broken (2+ pieces).It was not reported if there were any delays to the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.

• Brand Name: CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21103380
• Report Number: 1221934-2025-00116
• Device Sequence Number: 18430485
• Product Code: GEA
• UDI-Device Identifier: 10886705003570
• UDI-Public: (01)10886705003570(10)2109019(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 214116
• Device Lot Number: 2109019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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