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); Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

It was reported that during set up, the mdu got hot and then froze.The procedure was successfully completed without delay using a s+n back-up device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection found no issues.A functional evaluation revealed a handpiece sensor fault.Overheating of the device wasn't confirmed.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 concluded this was a repeat event.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 complaint of a handpiece sensor fault was confirmed, and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include a failure of the reed switch or damage on the hall board which may contribute to a short circuit.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: 12774663
• MDR Text Key: 282713839
• Report Number: 1643264-2021-02400
• 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: 04/01/2022

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
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/01/2022
• 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