MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 30°; ARTHROSCOPE

Model Number 72202087

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the negative lens of the a'scope a'clave was damaged.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11: further assessment of information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that no harm nor injury was reported and no previous injury or harm has been confirmed to be caused by the device in the past, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

H3,h6: the device, which was not 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.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.If the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: A'SCOPE, A'CLAVE, HD, 4MM X 30°
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9999322
• MDR Text Key: 189776844
• Report Number: 3003604053-2020-00027
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010616869
• UDI-Public: 03596010616869
• Combination Product (y/n): N
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202087
• Device Catalogue Number: 72202087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1