MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	214120
Medical Device Problem Codes	Leak/Splash (1354); Increase in Pressure (1491); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2025
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 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.H11 additional narrative: ¿ the product has not returned to j&j medtech orthopaedics; however, photos were provided for review.¿ visual inspection of the returned photos found that one of the silicone seals was detached from the device.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the clearcannula-threaded 8.5mmx75mm 5pk -st would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause can be traced to the procedural variables, such handling of the device or product interaction during procedure.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 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.Device history review = > 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.
Event or Problem Description
It was reported that during an unspecified surgical procedure it was observed that the clearcannula-threaded device was intruded through the port the clamps were introduced to recover the sutures and this presented water leakage through the inlet of the punch which causes the pressure in the joint to be lost, during cx a rubber part of the canula was observed inside the shoulder.There were no reports of delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.

• Brand Name: CLEARCANNULA-THREADED 8.5MMX75MM 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: 22865525
• Report Number: 1221934-2025-03215
• Device Sequence Number: 15787436
• Product Code: GEA
• UDI-Device Identifier: 10886705003617
• UDI-Public: (01)10886705003617(10)772408148(17)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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 Catalogue Number: 214120
• Device Lot Number: 772408148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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