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

Model Number	72200731
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up or inspection, the packaging of the acromioblaster burr was compromised, it was almost melted.There was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned devices found that they are in their original unopened packaging.The molded plastic capsules are shrunken and deformed.The white paper backing is warped due to the deformation of the clear plastic capsule.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 review of the device assembly found that device counts with a label specification sheet for guidance and final assembly structure.The root cause has been associated with transport/storage.Factors that could have contributed to the reported event include an inadvertent impact event that could have occurred during device transportation, rough shipping and handling, or at customer site.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 5.5MM ELITE ACROMIOBLASTER 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
• MDR Report Key: 14224642
• Report Number: 1219602-2022-00606
• Device Sequence Number: 17195526
• Product Code: HAB
• UDI-Device Identifier: 03596010578099
• UDI-Public: 03596010578099
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 09/06/2026
• Device Model Number: 72200731
• Device Catalogue Number: 72200731
• Device Lot Number: 50964442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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