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

Model Number	72200723
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the dyonics 5.5mm elite abrader burr was showing metal debris in the joint and rubbing on the inside shaft of the blade; the procedure was successfully completed without delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
One 72200723 dyonics 5.5mm elite abrader burr used during treatment, has not returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.The customer has provided images.The information provided states: ¿during surgery the dyonics 5.5mm elite abrader burr was showing metal debris in the joint and rubbing on the inside shaft of the blade, all material was removed¿.The image shows flaking on the device.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper use of device.Per ifu 10601209: ¿prior to deploying the cutting blade, ensure that the guide wire is retracted within the groove approximately 1.5 inches (38 mm) within the retrograde drill shaft and is not in the drill head window.The groove in the guide wire provides tactile feedback that it is retracted to the proper position.This will prevent possible device failure¿.Complaint history review was unattainable without a valid lot number and product code provided although query using entire elite abrader family indicated similar allegations.Batch review was unattainable without a valid lot number provided.Product met specifications upon release to distribution.

• 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
• MDR Report Key: 10445528
• Report Number: 1219602-2020-01302
• Device Sequence Number: 3872543
• Product Code: HAB
• UDI-Device Identifier: 03596010578013
• UDI-Public: 03596010578013
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 10/02/2020

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 Model Number: 72200723
• Device Catalogue Number: 72200723
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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: Required Intervention