MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN BLADE-BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number 0007

Device Problems Fire (1245); Self-Activation or Keying (1557); Sparking (2595); Inappropriate or Unexpected Reset (2959); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the dyonics power ii control unit beeped, shut off and turned back on and started grinding.The attached powermax hand control also started to grind and was shaving slowly.The physician removed it from the patient and the shaver handpiece started shaving without being turned on.Sparks and flames were also reported coming out of the end of the shaver.No patient or staff impact as a result.

Manufacturer Narrative

Device investigation narrative - a complaint history review has identified no additional complaints of this nature for this catalog number.Examination was not possible, as the device will not be returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.(b)(4).

• Brand Name: UNKNOWN BLADE-BURR
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5808800
• MDR Text Key: 50844330
• Report Number: 1219602-2016-00406
• Device Sequence Number: 0
• Product Code: NBH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1