MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED INCISOR PLUS ELITE BL,4.5MM,; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200036
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 72200036 curved incisor plus elite 4.5mm disposable blade used for treatment, was returned for evaluation.The complaint stated: ¿something was released from the device¿.Visual inspection showed the blade was used but in good condition.It spun freely.Light rotational scratches on the surface of the inner blade were found.Shedding symptoms have been found consistent with inadvertent pressure applied.Per instructions for use: ¿excessive side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.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.¿ binding, shavings and seizing may occur due to bone/tissue or metal shavings/fragments not excising efficiently via the pump settings.In addition, dark flaking has been found as consistent with tarnish due to silver plate and silicone processes.Moisture affects subsequent silver tarnish.Per technical data: ¿surillium is the proprietary, silver coating that helps prevent shedding.It improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.The red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.¿ silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.Complaint history lot review found no other complaints for this lot.Product met specifications upon release to distribution.Patient weight: (b)(6), report does not allow more than 3 characters.
Event or Problem Description
It was reported that during a knee scope, something was released inside the patient's anatomy from the device, as per reporter it could be oil or black pieces.No patient injuries or delay reported.Back-up device was available to complete the surgery.The black "scuff" marks were removed with additional shaving of the back-up device.
Event or Problem Description
It was reported that, during a knee scope, something was released inside the patient's anatomy from the device; it could be either oil or black pieces.The black "scuff" marks were removed with additional shaving of a back-up device, which was used to complete the surgery as well.No patient injuries or delay reported.

• Brand Name: CURVED INCISOR PLUS ELITE BL,4.5MM,
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8867755
• Report Number: 1219602-2019-00921
• Device Sequence Number: 11280327
• Product Code: HAB
• UDI-Device Identifier: 03596010555700
• UDI-Public: 03596010555700
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 03/07/2024
• Device Catalogue Number: 72200036
• Device Lot Number: 50792145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 92