MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6); SAW, POWERED, AND ACCESSORIES

Catalog Number	72200724
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it takes a lot of effort for the bone cutter to take some of the bone.The bone cutter blade produced small chips of metal in the joint.They were removed by flushing out.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
See c-(b)(4) eleven shelf cartons of product 72200724 (65 individual burrs; 10 cartons of 6 and one carton of were returned from lot 50741489.They are all new and unsealed.The product used in the procedure was not returned for evaluation.Definitive conclusions, accurate investigation and evaluation were not definitive without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location, tissue condition and use per product recommendations.Influences that could compromise product performance or integrity that are unrelated to manufacture include: blade hand piece not fully loaded and or locked into mdu hand set.Incompatible force, torque or leverage applied.Unexpected bone density/condition.Change of approach during use.Insufficient irrigation or engaging the device without suction.Seizing of blades due to inadequate bio matter excision.Use not compliant with instructions for use, tech guides or specific procedure.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).¿ final product met predetermined specs upon release to distribution.No patient harm or injury is being reported as a result of this device related incident, and all of the metal debris was flushed out.There is no indication of adverse patient consequence as a result.No further clinical assessment is warranted based on the information provided.Foreign zip code:(b)(4).Corrected.

• Brand Name: DYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8100013
• Report Number: 1219602-2018-01607
• Device Sequence Number: 1734500
• Product Code: HAB
• UDI-Device Identifier: 03596010578020
• UDI-Public: 03596010578020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 06/13/2023
• Device Catalogue Number: 72200724
• Device Lot Number: 50741489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1