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

Model Number 72200616

Device Problems Overheating of Device (1437); Electrical Shorting (2926)

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

Event Type  malfunction  

Event Description

It was reported that the motor drive unit got hot.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Manufacturer Narrative

B5, h6: medical device problem code.

Event Description

It was reported that the motor drive unit got hot.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.Upon investigation, it was found a short circuit as additional failure.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found a missing o-ring.A functional evaluation revealed a short circuit detected error message.No overheating was noted.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 of overheating was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.The short circuit error code was confirmed, and the root cause was associated with an electrical component failure.Factors that could have contributed to the reported event include incomplete potting on the hall board which may result in component failure, or corrosive damage on the hall board which may contribute to a short circuit.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: 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: 12888631
• MDR Text Key: 282730804
• Report Number: 1643264-2021-02438
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

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 Model Number: 72200616
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 04/27/2022; 12/05/2022
• Supplement Dates FDA Received: 04/27/2022; 12/06/2022
• 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: Unknown
• Patient Sequence Number: 1