MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6; SAW, POWERED, AND ACCESSORIES

Catalog Number 7206011

Device Problem Overheating of Device (1437)

Patient Problem Injury (2348)

Event Date 07/24/2019

Event Type  Injury  

Event Description

It was reported that during shoulder arthroscopy surgery, the shaver tip was overheated and burned the patient.A backup device was available to complete the procedure with no delay.The patient outcome is unknown.

Manufacturer Narrative

The reported 4.5 mm full radius blade, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade heated up and burned the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using the proper amount of irrigation recommended to provide adequate cooling of the blade.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BOXED F/R,BL,4.5MM,SERIES 3000 /6
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8883845
• MDR Text Key: 153983295
• Report Number: 1219602-2019-00951
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010440242
• UDI-Public: 03596010440242
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Catalogue Number: 7206011
• Device Lot Number: 50792131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1