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

Catalog Number 72200617

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a day surgery the motor drive unit overheated.After surgery was completed the nurse realized the patient had a first degree burn.It is unknown if a back up device was available.There was not a delay in the surgical procedure.The patient outcome is unknown.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.No clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.A visual inspection of the customer provided images revealed a 72200617 mdu with the serial number (b)(4), a 72200873 dyonics power ii control unit with the serial number (b)(4), and a tear in the cable insulation on the mdu's power 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 relationship, if any, between the subject device and the reported event could not be determined.The dyonics handpieces operations service manual warns to avoid patient burns, do not place the handpiece on the patient when it is not in use.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on product evaluation if the device is returning.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information; surgical procedure/post-operative care review; device labeling (including technique guides, ifus, etc.).No clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported mild 1st degree burn could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.

• Brand Name: MOTOR DRIVE UNIT NON-HAND CNTL PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8723697
• MDR Text Key: 148818581
• Report Number: 1643264-2019-00419
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010551559
• UDI-Public: 03596010551559
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72200617
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other