MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL MDU HAND CNTRL PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problems Mechanical Jam (2983); No Apparent Adverse Event (3189)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reported device, intended for use in treatment, 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 observed no issues.A functional evaluation revealed the blade stalled and the motor was not running.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the motor drive unit was not working.No case was involved.Results of investigation have concluded that this unit had a blade stall error which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed the blade stalled and the motor was not running.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was associated with a mechanical component failure.Factors that could have contributed to the failure include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: SVC REPL MDU HAND CNTRL PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10225260
• MDR Text Key: 197605431
• Report Number: 1643264-2020-00455
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/20/2022
• 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