MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL 4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Model Number	7210499
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the surgery the inner blade of a disposable blade 4.5mm fr elite could not be rotated when it was used and this caused the handpiece to get hot.There was no problem with the handpiece because overheating did not occur when another blades were connected to it and used.Surgery was completed using a smith and nephew back-up device.No patient injuries or delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned.The inner blade of the device had some markings on the metal from use.A functional evaluation concluded that this device was able to operate under the oscillate, forward, and reverse functions without incident.There was not excessive heat output from the device.The device had a tighter fit between the inner and outer blades, but it did not influence device operation.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 a repeat issue.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11271714
• Report Number: 1219602-2021-00245
• Device Sequence Number: 3440842
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/02/2021

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: 05/06/2025
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50871451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1