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

Model Number 72200616

Device Problems Leak/Splash (1354); Self-Activation or Keying (1557)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder arthroscopy acromioplasty, after the patient was moved to the operating room and the procedure began, the shaver started to operate by itself without surgeon's activation.The surgeon stopped the device and removed the tip, black oil came out of the device and dripped onto the operating table.The procedure was completed with a non-significant delay using a backup device.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection found a discolored cable.A functional evaluation was performed on the returned device and a noisy motor was found.The motor/gearbox could not be removed from the housing for further assessment.Self-activation and leaking were not noted during testing.It was determined the device contributed to the reported event.The complaint of self-activation was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.The complaint of black oil leaking was not confirmed.The noisy motor 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 or a short in the power cord.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.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 failures were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.Correction in h6 (medical device problem code).

Event Description

It was reported that during a shoulder arthroscopy acromioplasty, after the patient was moved to the operating room and the procedure began, the shaver started to operate by itself without surgeon's activation.The surgeon stopped the device and removed the tip, black oil came out of the device and dripped onto the operating table.The procedure was completed with a non-significant delay using a backup device.No further complications were reported.As per investigation results, noisy motor was found.

• 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: 13896532
• MDR Text Key: 287924025
• Report Number: 1643264-2022-00102
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Date Manufacturer Received: 06/16/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female