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

Catalog Number	72200730
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 bonecutter to take some of the bone.The bonecutter 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 or patient injuries.
Additional Manufacturer Narrative
Date of the event is unknown.
Additional Manufacturer Narrative
Additional information in: expiration date: (b)(4) 2023 device manufacture date: (b)(4) 2018 correction.Catalog number: 72200730 unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
One 72200730 dyonics 4.0mm acromioblaster burr product reported on.The complaint states: ¿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 or patient injuries.¿ the product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Shedding material condition has been found to be consistent with the device having inadvertent pressure applied while deburring which causes wear bands on the inner blade surface.The symptom points to excessive lateral load during use causing a mis-alignment of the inner and outer blade resulting in the shedding.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.Final product met predetermined specifications 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.

• 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: 8129019
• Report Number: 1219602-2018-01639
• Device Sequence Number: 11152181
• 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,Followup,Followup
• Report Date (Section B): 03/21/2019

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: 03/02/2023
• Device Catalogue Number: 72200730
• Device Lot Number: 50718389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 03/18/2019; 03/19/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/10/2018; 03/18/2019; 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1