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

Catalog Number 72200616

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Complaint of ¿burnt smell¿ has been confirmed.Motor is stalled and will not rotate.The cable assembly was removed from the motor housing and revealed a strong burnt smell.Corrosion was found inside motor housing.Motor could not be removed due to excessive corrosion.It appears that this unit has leaked over time and corrosion has caused the motor to stall which in turn has caused a short circuit in the control unit.Records show that this unit was last serviced at the (b)(4) service center on (b)(6) 2012 and sent to (b)(4) as a service exchange.Unit requires repair.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation the root cause for the reported issue was found to be expected wear and tear.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that during a hip arthroscopy procedure that the shaver hand piece stated to get warm and suddenly the shaver controller started to send out much smoke.No patient injury or delay was reported.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5266563
• MDR Text Key: 32900966
• Report Number: 1643264-2015-00191
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Device Lot Number: AAL44907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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