MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205305

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a material that was coming out of the blade.It seemed to be little shavings of some sort.The debris was flushed from the patient and the procedure was completed with a backup s&n device.No patient impact as a result.There was a reported delay of less than 30 minutes.

• Brand Name: FULL RADIUS BLADE,3.5MM,DISP
• 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: james gonzales james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5958520
• MDR Text Key: 55330631
• Report Number: 1219602-2016-00652
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: 7205305
• Device Lot Number: 50578231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1