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

Model Number 72200616

Device Problem Power Problem (3010)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of switching on/off could not be reproduced.Product failed for handpiece sensor fault, thus the buttons do not function.Switching on/off did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during the set up inspection, the mdu was switching on and off by itself.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 11343962
• MDR Text Key: 232546307
• Report Number: 1643264-2021-00713
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2021

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: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/18/2021
• 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