MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM; ARTHROSCOPE

Model Number	72202087S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a knee arthroscopy, the arthroscope was not working.The procedure was completed with a delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.
Event or Problem Description
It was reported that, during a knee arthroscopy, the arthroscope had picture issues.The procedure was completed with a delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was returned to the designated complaint unit for independent evaluation.A visual inspection of returned device found distal tip damage, sidearm damage, negative lens damage, dented and bent needle.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A complaint history review of the part found similar events.There was a relationship found between the device and the reported event.The complaint was confirmed, and the root cause was associated with an unintended use of the device.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: SERV REPL ASCOPE A/C HD 30 DEG 4MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15535516
• Report Number: 3003604053-2022-00052
• Device Sequence Number: 20791348
• Product Code: HRX
• UDI-Device Identifier: 03596010644534
• UDI-Public: 03596010644534
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2023

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: 72202087S
• Device Catalogue Number: 72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 01/16/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/11/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown