MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ABRADER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200723
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a procedure the dyonics abrader burr had excessive metal flaking.The flaked visible material was retrieved from the patient with suction.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The inner surface of the outer shaft and the outer surface of the inner shaft have a ring of scoring with metal flaked off in the proximal quarter of the shafts.There is biological debris on the returned items.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: DYONICS 5.5MM ELITE ABRADER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19927965
• Report Number: 1219602-2024-01672
• Device Sequence Number: 11458602
• Product Code: HAB
• UDI-Device Identifier: 03596010578013
• UDI-Public: 03596010578013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Catalogue Number: 72200723
• Device Lot Number: 51209678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown