MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLUSH SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC

Model Number	72203053
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the set up inspection, the cutting piece broke off of the suture cutter.Backup device was available to complete the procedure.No delay and no patient injuries were 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 flush suture cutter, intended for use in treatment, has been returned for evaluation.The device is over three years old.Visual assessment of the device confirmed the complaint.The movable jaw has come free from the actuator and shaft and was not returned.Examination of the handle, shaft and actuator showed no abnormalities.Without the return of the movable jaw an exact root cause cannot be determined with confidence.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: FLUSH SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10343863
• Report Number: 1219602-2020-01160
• Device Sequence Number: 19047548
• Product Code: NBH
• UDI-Device Identifier: 03596010653666
• UDI-Public: 03596010653666
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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 Model Number: 72203053
• Device Catalogue Number: 72203053
• Device Lot Number: 50643975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1