MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO ASCOPE ACLAVE HD 4MM X 45 DEG; ARTHROSCOPE

Model Number	72202089
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, part of the tip came off from the scope and fall off inside of the patient.The piece was removed from the patient.The procedure was successfully completed with ninety minutes of delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H10 h3, h6 the reported device was received for evaluation.A visual inspection found a missing distal outer tube keel, distal tip damage, sidearm damage, scratches on the needle, and residue on external optical surfaces.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Per case details, the tip was retrieved from the patient.Should any additional clinical information be provided this complaint will be re-evaluated.The instruction for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A complaint history review concluded this was an isolated event.A review of the customer images confirmed the product information.The images showed internal components of the scope had separated from rest of the device.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 review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.It was determined the device did not contribute to 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.

• Brand Name: MTO ASCOPE ACLAVE HD 4MM X 45 DEG
• 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: 12686879
• Report Number: 3003604053-2021-00253
• Device Sequence Number: 4028005
• Product Code: HRX
• UDI-Device Identifier: 03596010616883
• UDI-Public: 03596010616883
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202089
• Device Catalogue Number: 72202089
• Device Lot Number: BBL917371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 01/17/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown