MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 70°; ARTHROSCOPE

Model Number	72202088
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy of the left joint knee, synovectomy, joint cavity cleaning, use opposite gracilis femoris and semitendinosus tendon to repair and reconstruct the anterior cruciate ligament, suture of the lateral meniscus and suture of the medial collateral ligament of the left knee were performed.After surgery, x-ray examination was performed and showed there were suspicious metal foreign bodies in the left knee and patient swelling about left knee.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, which was used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found related failures.A clinical review was performed and based on the limited information provided the root cause of the reported issue could not be determined.Although the scope is a medical instrument, it, itself should not have components that shed fragments unless it was hit by a shaver or some other device.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.Catalog number updated.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 70°
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9545991
• Report Number: 3003604053-2020-00002
• Device Sequence Number: 16713313
• Product Code: HRX
• UDI-Device Identifier: 03596010616876
• UDI-Public: 03596010616876
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K0962075
• 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): 03/01/2020

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 Model Number: 72202088
• Device Catalogue Number: 3895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1