MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,4.0 ELITE ABRADER 6/BX; SAW, POWERED, AND ACCESSORIES

Model Number 72200722

Device Problem Metal Shedding Debris (1804)

Patient Problems No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 12/29/2017

Event Type  malfunction  

Event Description

It was reported that the device shed metal shavings, all were removed from the patient.No significant delay or patient injury 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.

• Brand Name: BLADE,4.0 ELITE ABRADER 6/BX
• 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: 7181796
• MDR Text Key: 97092218
• Report Number: 1643264-2018-00037
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010578006
• UDI-Public: (01)03596010578006(17)220512(10)50664175
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: 72200722
• Device Catalogue Number: 72200722
• Device Lot Number: 50664175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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