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

Catalog Number 72200616

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/26/2018

Event Type  Injury  

Event Description

It was reported that after a femoral osteoplasty, the patient removed the bandages and found what appeared to be a burn/blister.The patient went to the clinic and the surgeon thought there was potential that the shaft of the arthroscopy burr and or handpiece getting warm and coming in contact with the patient¿s skin could have caused it while he was performing the femoral osteoplasty.2 cm posterior to the inferior surgical incision on the lateral hip there is a 3 cm fluid filled blister.Surgery revision was not performed.Attempts were made to retrieve further information but no response was received from the complainant.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No relevant supporting clinical/medical information or photos have been provided; therefore a thorough clinical analysis cannot be rendered.A relationship, if any, between the subject device and the reported event could not be determined.The dyonics handpieces instructions for use cautions not to operate the handpiece in the open air for an extended period, as lack of irrigation may cause the motor or blade to overheat and seize.It also states to avoid patient burns, do not place the handpiece on the patient when it is not in use.

• 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 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8251477
• MDR Text Key: 133202886
• Report Number: 1643264-2019-00049
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 12/24/2018; 04/02/2019
• Supplement Dates FDA Received: 01/23/2019; 04/04/2019
• 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 Outcome(s): Other