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

Model Number	72200725
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during use instruments inside the patient in an arthroscopy, the blade shredded off, they managed to remove the debris but the inner blades seemed to become stuck and therefore was unable to rotate.All remaining material was removed from surgical site.The procedure was completed with a s+n back-up device.No significant delay was reported, and no other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).H3, h6: ¿the device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the device was received outside of original packaging.The distal tip of the inner blade appears to have what appears to be sluff chamber debris.No physical damage visible to the distal tip of the inner blade or outer blade.The sluff chamber appears to have started melting together.A functional evaluation revealed the device functioned clockwise, counter clockwise, and while oscillating as intended without excessive noise or grinding.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include running the device with inadequate or no suction and irrigation.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 5.5MM ELITE ACROMIONIZER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12096013
• Report Number: 1219602-2021-01477
• Device Sequence Number: 17147254
• Product Code: HAB
• UDI-Device Identifier: 03596010578037
• UDI-Public: 03596010578037
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 72200725
• Device Catalogue Number: 72200725
• Device Lot Number: 50779892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other