MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 4.0 EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205324
Medical Device Problem Codes	Overheating of Device (1437); Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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 that the inner and outer blades of the burr were returned.There was melting evident on the sluff chamber.There was debris present on the inner blade and around the shaft.  an analysis of the customer provided images confirmed the batch number of the device and the reported melting.  a review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The complaint was confirmed.Factors that could have contributed to the reported event include insufficient irrigation or lack of irrigation.No containment or corrective actions are recommended at this time.Reference: (b)(4).
Event or Problem Description
It was reported that during the surgery, in less than one minute after the blade was used the colloid melted at the interface between the blade and the wire.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.Results of investigation have concluded that there was debris on the inner blade, which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: ABRADER 4.0 EP-1 DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11359483
• Report Number: 1219602-2021-00380
• Device Sequence Number: 11700700
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 09/15/2023
• Device Model Number: 7205324
• Device Catalogue Number: 7205324
• Device Lot Number: 50759043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1