MAUDE Adverse Event Report: MENTOR TEXAS BECKER 4MM X 32CM LARGE HANDLE CANNULA; SYSTEM, SUCTION, LIPOPLASTY

Model Number	BEC432L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that prior to surgery, the tip of a becker 4mm x 32cm large handle cannula had broken.There was no patient involvement and no delays in surgery were reported.
Additional Manufacturer Narrative
A photo of the device was returned for evaluation.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the cannula was observed broken at the tip near the handle.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.Although the product was not received, the manufacturing records of the 16012701 lot number provided were identified.The manufacturing records were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: BECKER 4MM X 32CM LARGE HANDLE CANNULA
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9949407
• Report Number: 1645337-2020-05538
• Device Sequence Number: 14311503
• Product Code: MUU
• UDI-Device Identifier: 00081317020738
• UDI-Public: 00081317020738
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 07/31/2021
• Device Model Number: BEC432L
• Device Catalogue Number: BEC432L
• Device Lot Number: 16012701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1