MAUDE Adverse Event Report: DEPUY MITEK CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST; ARTHROSCOPIC DRAINAGE CANNULA

Catalog Number	214116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
The sales rep reported via phone that at the end of a shoulder arthroscopy the surgeon noticed that there was a clear plastic piece in the patients joint space.The surgeon looked at the 7.0x75mm fully threaded cannula that was used in the case and noticed taht it was damaged.The surgeon went back into the patient and used a shaver to remove the plastic piece.The surgeon was confident that he had removed the piece but the first assist stated that the piece was still in the patient.The surgeon felt confident it was removed and close the patient up without any issues.There were no patient consequences or delays.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.The date device returned to manufacturer has been corrected.Investigation summary: the complaint devices was received and evaluated visually.On visual inspection, the top silicon seal was found cracked but no parts missing on the device.It was reported that a plastic piece was found in the patients joint space and the surgeon claimed the used device was damaged.It is unclear that what part of the device fell into the patient as there is no broken/missing part from the device.The complaint is not confirmed as there is no part missing on the device.At the time of the investigation, the root cause of the failure mode is undetermined.Review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the records reviewed.A review into the depuy synthes mitek complaints system revealed no other complaints for this device's lot number.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Udi: (b)(4).

• Brand Name: CLEARCANNULA-THREADED 7.0MMX75MM 5PK -ST
• Common Device Name: ARTHROSCOPIC DRAINAGE CANNULA
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7084294
• Report Number: 1221934-2017-50036
• Device Sequence Number: 780977
• Product Code: GEA
• UDI-Device Identifier: 10886705003570
• UDI-Public: 10886705003570
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2017
• Report Date (Section F): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 214116
• Device Lot Number: 1610028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/04/2017; 10/09/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/09/2018; 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other