MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEAR CANNULA SYSTEM 8.5 X 90 MM ¿ THREADED; ARTHROSCOPIC DRAINAGE CANNULA

Model Number 214122

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 06/21/2022

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.H10 additional narrative: udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.H4: the device manufacture date is currently unavailable.Investigation summary: the complaint device was received and evaluated.Upon visual inspection, it could be observed that the cannula is showing the silicone bung damaged.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.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 reported failure can be attributed 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.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

It was reported by the healthcare professional in brazil that during an unknown orthopedic procedure on (b)(6) 2022, it was observed that the clear cannula system 8.5 x 90 mm ¿ threaded device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the cannula was showing the silicone bung damaged.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: CLEAR CANNULA SYSTEM 8.5 X 90 MM ¿ THREADED
• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16898325
• MDR Text Key: 314900009
• Report Number: 1221934-2023-01994
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886705003631
• UDI-Public: 10886705003631
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214122
• Device Catalogue Number: 214122
• Device Lot Number: 210596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male