MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5MM FLAT TOP 180MM LG HIGH VISI; SAW, POWERED, AND ACCESSORIES

Model Number	72203129
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unspecified surgery, after turning off and on the 5.5 mm high visibility blade, it did not spin and got stuck so the product began to heat and then burned.Although it is unknown how the surgery was completed, the surgery was not significantly delayed.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one 72203129 5.5mm 180mm long, high visibility flat top burr device used for treatment, was returned for evaluation.Instruction for use confirms precautionary statements and recommendations for proper use of product.Visual evaluation confirmed that the burr had melted components and had seized up.The inner burr component no longer rotates.Overheating, melted material condition is aligned with devices being tested or run without or with inadequate suction and irrigation.Per instruction for use: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).¿ binding and seizing may occur due to bone, tissue or metal shavings, fragments not excising efficiently.Per instruction for use: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review indicated no similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
B5: event description updated.
Event or Problem Description
It was reported that, during an arthroscopic hip surgery, after turning off and on the 5.5 mm high visibility blade, it did not spin and got stuck so the product began to heat and then burned.Surgery was completed, without any significant delay by using a back-up device.The patient was not harmed.
Additional Manufacturer Narrative
H10 h3, h6: the reported 5.5mm x 180mm long high visibility flat top burr, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the burr did not spin and got stuck so the product began to heat and then burned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: periodic irrigation of the burr not being performed to provide adequate cooling of the burr.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BURR 5.5MM FLAT TOP 180MM LG HIGH VISI
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9831061
• Report Number: 1219602-2020-00523
• Device Sequence Number: 16328750
• Product Code: HAB
• UDI-Device Identifier: 03596010655318
• UDI-Public: 03596010655318
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 72203129
• Device Catalogue Number: 72203129
• Device Lot Number: 50735559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 04/10/2020; 05/27/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/19/2020; 04/14/2020; 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1