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

Catalog Number 72200616

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

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

Event Date 12/16/2014

Event Type  malfunction  

Manufacturer Narrative

Device has been received, evaluation anticipated, but not yet begun.Smith & nephew will continue to monitor for any future occurrences of this failure type.No further action is deemed necessary as a result.(b)(4).

Event Description

An electrical short and sparking was noted during a surgical procedure.

Manufacturer Narrative

One powermax elite, part number 72200616 was received on 12/30/2014 and confirmed to be serial number (b)(4) as reported in the complaint.The reported complaint of ¿sparking¿ could not be confirmed however functional testing has found that the motor has seized and will not rotate; disassembly of the motor was not possible as the motor is stuck inside the housing as a result of internal corrosion.It appears that this unit has leaked over time from exposure to cleaning and sterilization.A document review has shown that this unit was originally shipped in july of 2014.Internal corrosion to this degree is unusual for a unit that is only 5 months old.The care and handling method used by this customer is unknown therefore it is recommended that the user refer to the recommendations for care and handling that can be found in the powermax elite operations manual.Serial number: (b)(4) this is not a lot number or "other" number.Device is reusable and therefore is not labeled for single use.

• 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: 5015898
• MDR Text Key: 24586558
• Report Number: 1643264-2015-00123
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: AAL66180
• Other Device ID Number: AAL66180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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