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

Model Number 7205314

Device Problem Metal Shedding Debris (1804)

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

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient initials: (b)(6).

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 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.

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
• 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: 7287437
• MDR Text Key: 100770650
• Report Number: 1219602-2018-00249
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251428
• UDI-Public: (01)03596010251428(17)210121(10)50583748
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1