MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4KO VIDEOARTHROSCOPE AC 4X30X160MM

Model Number	72205149
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the scope was cracked on the tip of the lens during set up for an unspecified procedure.There was a smith and nephew backup device available.No patient injuries, delays or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found distal tip and fiber damage, broken lenses, and distal lens damage.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 issue.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: 4KO VIDEOARTHROSCOPE AC 4X30X160MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11828834
• Report Number: 3003604053-2021-00195
• Device Sequence Number: 16409077
• Product Code: HRX
• UDI-Device Identifier: 00885556735954
• UDI-Public: 00885556735954
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 72205149
• Device Catalogue Number: 72205149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1