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

Catalog Number	7206011
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8883845
• Report Number: 1219602-2019-00951
• Device Sequence Number: 2397363
• Product Code: HAB
• UDI-Device Identifier: 03596010440242
• UDI-Public: 03596010440242
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2021
• Device Catalogue Number: 7206011
• Device Lot Number: 50792131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1