MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ROTARY SCISSORS 20DEG HOOKED RIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 010801

Device Problem Corroded (1131)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that the rotary scissors were found to be rusted.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: 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 complaint history review concluded this was an isolated event.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 review of the customer provided images found two images showing discoloration resembling rust on the handle of the device.A visual inspection of the returned device found that it was not in its original packaging.The markings on the device confirm the product identification information.There is corrosion on the handle of the device.The complaint was confirmed.Factors that could have contributed to the reported event include improper storage conditions or improper routine maintenance of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: ROTARY SCISSORS 20DEG HOOKED RIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12011993
• MDR Text Key: 256733885
• Report Number: 1219602-2021-01379
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010022066
• UDI-Public: 03596010022066
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 010801
• Device Catalogue Number: 010801
• Device Lot Number: T115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1