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

Catalog Number 72200616

Device Problems Overheating of Device (1437); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2019

Event Type  malfunction  

Event Description

It was reported that the surgeon was performing arthroscopic acromioplasty, whilst using dyonics powermax elite, the handpiece stopped working,they tried to get it to work but it appeared there was a problem with the motor mechanism and handpiece was heating up.No patent injury was reported.It is unknown if there was a procedure delay or a backup device available.

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.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

Correct part number: 72200616.

• 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: 8644298
• MDR Text Key: 146234365
• Report Number: 1643264-2019-00372
• 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,Followup
• Report Date: 07/15/2019

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 Catalogue Number: 72200616
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/27/2019
• Supplement Dates Manufacturer Received: 07/09/2019; 07/15/2019
• Supplement Dates FDA Received: 07/10/2019; 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1