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

Model Number	7210499
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during arthroscopic shoulder surgery, the surgeon was complaining of shedding on the shaver blade.The procedure was completed with the same device and no other complications were reported.Minor delay to clear metal shavings from joint.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference: case(b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed debris on the inner and outer blades.Some of the debris was reflective within the inner blade, implying metal shavings.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the instructions for use revealed the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Dyonics disposable arthroscopic blades contain magnets that may be attracted to other instrumentation when placed in direct contact.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.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.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include excessive side-loading and minimal irrigation.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10871705
• Report Number: 1219602-2020-01887
• Device Sequence Number: 16957356
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 08/05/2025
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50888793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention