MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISP KNIFE ROUND TIP (BX 5); ACCESSORIES,ARTHROSCOPIC

Model Number	010620
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during hip arthroscopy, the acufex would not fit down on the blue hip scope cannula, one of the blades had a wider handle.No backup device was available.It is unknown if a delay was caused due to the device malfunction.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: additional information was received from reporter stating that there was a back-up device available to complete procedure.Although a device malfunction, the procedure was finished as intended without any other medical intervention with an equivalent device, with no significant delay or complication.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: DISP KNIFE ROUND TIP (BX 5)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9516548
• Report Number: 1219602-2019-01620
• Device Sequence Number: 3461648
• Product Code: NBH
• UDI-Device Identifier: 03596010032690
• UDI-Public: 03596010032690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/03/2020

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: 01/30/2024
• Device Model Number: 010620
• Device Catalogue Number: 010620
• Device Lot Number: 2027581
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1