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

Catalog Number 72200616

Device Problems Defective Component (2292); Electrical Shorting (2926)

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

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issues were found.A functional evaluation revealed the power cord had a short.The complaint was confirmed and the root cause has been associated with an electrical component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

Event Description

It was reported that the motor was bad.According to product evaluation, the power cord shorted out.No case involved.No injuries were 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7733533
• MDR Text Key: 115577438
• Report Number: 1643264-2018-00563
• Device Sequence Number: 0
• Product Code: HAB
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2018

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: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1