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

Catalog Number 72200616

Device Problem Mechanical Problem (1384)

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

Event Date 08/22/2019

Event Type  malfunction  

Event Description

It was reported that during a knee procedure, 2 buttons of the device were going on and off.Backup device was available to complete the procedure.No delay and no patient injuries were reported.

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 and no issues were noted.Mdu would start and stop running each time the housing was slightly shaken.Cause of intermittent start/stop is a corroded right button assembly.Mdu also fails intermittently for hand piece error when plugged into the control unit.The complaint was confirmed and the root cause has been determined to be corrosion of the right button assembly.Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time.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.

• 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: holly topping ; 7000 w william cannon drive; austin, TX 78735 ; 5123913906
• MDR Report Key: 9070177
• MDR Text Key: 164298225
• Report Number: 1643264-2019-00640
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/20/2019
• 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: Unknown
• Patient Sequence Number: 1