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

Model Number 72202087S

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).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 and cracked and scratched distal lens.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 event.The instructions 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 review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.

Event Description

It was reported that during the set up inspection for an acl procedure, the scope lens was cracked.A backup device was available to complete the procedure.No delay and no patient injuries were reported.Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SERV REPL ASCOPE A/C HD 30 DEG 4MM
• Type of Device: 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: 11693778
• MDR Text Key: 262227488
• Report Number: 3003604053-2021-00166
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010644534
• UDI-Public: 03596010644534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202087S
• Device Catalogue Number: 72202087S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1