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

Model Number 72200616

Device Problems Unintended Power Up (1162); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Event Description

It was reported that during setup the mdu was broken.The procedure was completed without delay using a back-up device.There was no patient involvement.As per investigation results, a stuck left button causing the device to run intermittently was found.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference case-(b)(4).The reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection revealed a discolored cable.A functional evaluation was performed on the returned device and a stuck left button causing the device to run intermittently.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 has been associated with a mechanical component failure.Factors that could have contributed to the event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over 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.Correction in h6 (medical device problem code).

• 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
• 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: 16284441
• MDR Text Key: 308661448
• Report Number: 1643264-2023-00067
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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 Model Number: 72200616
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/18/2023
• 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