MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 6.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72200427
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a shoulder arthroscopic stabilization, the cannula broke while was in patient.Pieces taken out of patient.The procedure was completed with the same device before to know that it was broken, with no significant delay and no patient injuries.
Additional Manufacturer Narrative
Threaded flexible 6.5x72mm cannula device used for treatment, was not returned for evaluation.These are sold as a shelf carton of qty 10.These are not to be sold individually.There was a relationship between the reported event and the device.Due to unavailability, the allegation could not be physically confirmed.Definitive conclusions, investigation and evaluation were limited.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage and transit, surgical and device ability, procedure location and tissue condition.Caution to avoid torque and force should be used for all devices.Root cause related to the manufacture of the device was not confirmed.Product met specifications upon release to distribution.Complaint history review found no similar reports for this part/lot number.¿.

• Brand Name: CANNULA THREADED FLEX 6.5 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8643288
• Report Number: 1219602-2019-00605
• Device Sequence Number: 2016779
• Product Code: NBH
• UDI-Device Identifier: 03596010597045
• UDI-Public: 03596010597045
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 72200427
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1