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

Catalog Number 72200616

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

It was reported that the device was running without pushing buttons.No patient was involved.

Manufacturer Narrative

There was a relationship found between the returned device and the reported incident.A visual inspection was performed and no issues were noted.Complaint of hand piece running on its own was confirmed.Product ran on its own when hand piece was shaken or moved about.Cause of running intermittently without pressing a button is a partially stuck forward button.The complaint was confirmed and the root cause has been determined to be a defective button switch.Factors that could have contributed to the reported event include a burr in the bushing, a bad finish on the stem, or a defective spring.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.Device evaluated by the manufacturer.

• 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
• MDR Report Key: 7594631
• MDR Text Key: 111156502
• Report Number: 1643264-2018-00452
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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