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

Model Number 7205314

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2018

Event Type  Malfunction  

Event 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 were from the blade when it was used with the shaver handpiece, the particles were removed from the tissue by irrigation - suction. No patient injury was reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device. A review of the non-conformities database was performed which confirmed no abnormalities were reported with this lot during manufacture. A complaint history review identified no additional complaints for this manufactured lot.

• Brand Name: INCISOR, 5.5MM,EP-1,DSPL BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7405316
• MDR Text Key: 104818700
• Report Number: 1219602-2018-00418
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,FOREIGN,HEALTH PR
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/06/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 7205314
• Device Catalogue Number: 7205314
• Device LOT Number: 50632650
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/22/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial