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

Model Number 72200616S

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

It was reported that the device overheats.No significant delay or patient injury reported.

Manufacturer Narrative

Patient information received.

Manufacturer Narrative

There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Product passed functional and high speed testing (100-10,000 rpms) for 10 minutes in both forward and reverse directions.Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch.Current draw was average for this product and overheating did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• 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
• MDR Report Key: 6889002
• MDR Text Key: 87510302
• Report Number: 1643264-2017-00570
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010565105
• UDI-Public: (01)03596010565105
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200616S
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 15 YR