MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT,ULTRALIGHT W/; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205971

Device Problems Overheating of Device (1437); Positioning Problem (3009)

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

Event Date 10/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the unit was not rotating and the hand piece gets heated.No patient injuries were reported.

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 relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

Event Description

It was reported that before the procedure, the unit was not rotating and the hand piece got heated.There was no patient involvement.

• Brand Name: MOTOR DRIVE UNIT,ULTRALIGHT W/
• 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: 8071087
• MDR Text Key: 127207865
• Report Number: 1643264-2018-00872
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010445834
• UDI-Public: 03596010445834
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• 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