MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE 1.9MM X 30; ARTHROSCOPE

Model Number	4184S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a bent needle, distal tip and fiber damage, sidearm lens damage, and a cracked compact.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat event.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
Event or Problem Description
It was reported that the scope was not working.No patient was involved as the event occurred after the surgery.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.Results of investigation have concluded that this unit had a cracked compact which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SVCE REPL ASCOPE 1.9MM X 30
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11693809
• Report Number: 3003604053-2021-00167
• Device Sequence Number: 19744421
• Product Code: HRX
• UDI-Device Identifier: 03596010125569
• UDI-Public: 03596010125569
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 4184S
• Device Catalogue Number: 4184S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1