MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST; ARTHROSCOPIC DRAINAGE CANNULA

Model Number 214120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Not Applicable (3189)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi:(b)(4) lete the lot number is unknown at this time.

Event Description

It was reported by affiliate via complaint submission tool, the clearcannula-threaded 8.5mmx75mm 5pk -st.During a shoulder operation, the sealing ring came loose from the threaded clear cannula with obturator 8,5 mm x 75 mm.Sealing ring was thus free in the patient's shoulder joint.Fortunately, we were able to remove the exposed sealing ring.There was a surgical delay of 5 minutes.No patient consequences.The device is available to be returned for evaluation.

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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H10 additional narrative: investigation summary: event description: it was reported by affiliate via complaint submission tool, the clearcannula-threaded 8.5mmx75mm 5pk -st.During a shoulder operation, the sealing ring came loose from the threaded clear cannula with obturator 8,5 mm x 75 mm.Sealing ring was thus free in the patient's shoulder joint.Fortunately, we were able to remove the exposed sealing ring.There was a surgical delay of 5 minutes.No patient consequences.The device is available to be returned for evaluation.Investigation summary: the device was received and inspected at cq.Upon visual inspection, it was noticed that the 2 out of 3 of the silicon seals were missing from cannula body.Hence, the complaint can be confirmed for falling apart issue.No definitive root cause could be determined.It is possible excessive force was applied due to repeated movement which might have caused the reported failure.A manufacturing record evaluation was performed for the finished device [1906058] number, and no non-conformances related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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.H10 additional narrative: d4: the lot number and expiration date were reported as unknown on the initial report and has been updated accordingly.Therefore, udi: (b)(4).H6: method codes: a manufacturing record evaluation was performed for the finished device [1906058] number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: CLEARCANNULA-THREADED 8.5MMX75MM 5PK -ST
• Type of Device: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10525410
• MDR Text Key: 206792488
• Report Number: 1221934-2020-02570
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10886705003617
• UDI-Public: 10886705003617
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214120
• Device Catalogue Number: 214120
• Device Lot Number: 1906058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/09/2020
• Patient Sequence Number: 1