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

Model Number	7210499
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an ls arthroscopic rotator cuff procedure, two tiny pieces of metal broke free from the reprocessed shaver blade.The joint was irrigated profusely and the metal pieces washed out of the joint into the suction collection.A back-up device was available to complete the procedure.Surgical delay or patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7210499 disposable 4.5mm full radius elite blade used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was.If further information becomes available the complaint may be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.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.Make sure the hand piece is off while changing blade tip position.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).¿ the lot number reported could not be confirmed in our records.Complaint history review for three years prior indicated similar allegations for the product code reported.Batch review was unattainable without a verifiable lot number provided.No indications suggest the product did not meet specifications upon release to distribution.

• Brand Name: DISPOSABLE BL,4.5MM FR ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9734292
• Report Number: 1219602-2020-00258
• Device Sequence Number: 16918668
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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 Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 2061453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 79