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

Catalog Number 72200616

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

One powermax elite motor drive unit, part number 72200616 was received on august 23, 2017 and confirmed to be serial number (b)(4).There was a relationship found between the returned device and the reported incident.Complaint of ¿keeps running¿ was confirmed.The mdu failed for hand piece error.Cause of error is a stuck button.The forward direction button was depressed, stuck in the ¿on¿ position due to extreme corrosion.Button spring was completely rusted and collapsed.Collapsed button is the cause of ¿keeps running¿ stated in complaint.Mdu is over 5 years old.Mdu passed functional testing after button spring was unstuck.No containment or corrective actions are recommended at this time.The complaint investigation has concluded that the device has exceeded its recommended service life limit and has succumbed to expected wear and tear.

Event Description

According to the customer the device kept running during the procedure.No patient or user injury was reported.A backup device of the same kind was available.

• 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 ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6820115
• MDR Text Key: 83747133
• Report Number: 1643264-2017-00502
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Device Lot Number: AAL44562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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