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

Model Number	72200616F
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with motor stall and overheating of cord.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.It was determined that the power cord has shorted internal wiring.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.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.(b)(4).
Event or Problem Description
It was reported that the rfb mdu hand cntrl pwrmx el overheated and stopped working.It is unknown whether the event happened during surgery and if there was patient involvement.Also unknown how the procedure was finished or is there was any delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RFB MDU HAND CNTRL PWRMX EL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11619342
• Report Number: 1643264-2021-01285
• Device Sequence Number: 19799929
• Product Code: HAB
• UDI-Device Identifier: 03596010601209
• UDI-Public: 03596010601209
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 72200616F
• Device Catalogue Number: 72200616F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1