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

Model Number	72200427
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup when the package was opened it was found that the tip of the cannula was chipped.There was backup device available, no delay or patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 6.5 x 72mm threaded flexible cannula, intended for use in treatment, has been returned for evaluation.Visual assessment confirmed the reported complaint.The distal end of the cannula is damaged.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: device impacted in some manner.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: CANNULA THREADED FLEX 6.5 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10350851
• Report Number: 1219602-2020-01161
• Device Sequence Number: 19489073
• Product Code: NBH
• UDI-Device Identifier: 03596010597045
• UDI-Public: 03596010597045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 09/21/2022
• Device Model Number: 72200427
• Device Catalogue Number: 72200427
• Device Lot Number: 427190928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1