MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616

Device Problems Melted (1385); Overheating of Device (1437); Self-Activation or Keying (1557)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

Prior to a shoulder arthroscopy procedure using a motor drive unit, hand cntrl, pwrmx el, it was reported that the shaver handpiece had started up by itself.The shaver handpiece, the cord and the plug that connected the shaver handpiece to the shaver unit became so warm, that parts of the draping material that the devices were laying on began to melt.Backup devices were available to complete the procedure.The incident occurred during preparation for the surgery so the patient was not involved in the incident.The patient¿s condition post-procedure was reported as okay.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

One powermax elite mdu (handpiece), serial number (b)(4), one dyonics ii controller, serial number (b)(4), and one foot switch, serial number (b)(4) were received on or about 6/15/2015.All three units were tested together as a system.When connecting the mdu (hand piece) to the controller, the controller display gave the error ¿short circuit detected¿ unit also gave an audible alarm.At this point, the system was dismantled and all three pieces were tested individually.The mdu and footswitch were confirmed to be functioning properly, no problems were found however, the dii controller was found to have damaged electronic components as a result of a short circuit.The cause of the short circuit is unknown.The reported complaint of ¿handpiece started by itself¿ could not be confirmed, all mdu hand controls function as intended.It is also unknown how long the hand piece (mdu) was allowed to run unattended, excessive run time may have contributed to the reported overheating.It is possible that the electronic component damage may have happened previously but first detected during the reported event.The complaint investigation has concluded that there is insufficient information to determine the exact cause of the reported event.(b)(4).

• Brand Name: MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4887708
• MDR Text Key: 6539773
• Report Number: 1643264-2015-00033
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 72200873 (B)(4) DII CONTROLLER