MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205314
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient initials: (b)(6).
Event or Problem Description
It was reported that during the procedure, when it was using the 5,5 mm blade, some silver particles were observed in the tissue, the doctor realized that they are from the blade when it was used with the shaver handpiece, the particles were removed from the tissue by irrigation - suction.No patient injury reported.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: INCISOR, 5.5MM,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7287437
• Report Number: 1219602-2018-00249
• Device Sequence Number: 1066915
• Product Code: HAB
• UDI-Device Identifier: 03596010251428
• UDI-Public: (01)03596010251428(17)210121(10)50583748
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 01/21/2021
• Device Model Number: 7205314
• Device Catalogue Number: 7205314
• Device Lot Number: 50583748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1