MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWER SAGITTAL SAW; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205786

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported the device does not work at all times when the handle is pressed.Sometimes though, it will stay permanently on even when switched to safe mode.No injuries or complications were reported as a result.

Manufacturer Narrative

The device was received and sent to the original equipment manufacturer (oem) for evaluation.There was a relationship found between the returned device and the reported incident.Evaluation of the device by the oem found the unit did not run.When disassembled it was found that the motor had failed and the lohet was cracked.The complaint was confirmed and per the oem the root cause was determined to be wear from use.

• Brand Name: DYONICS POWER SAGITTAL SAW
• 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 6802659
• MDR Text Key: 83105297
• Report Number: 1643264-2017-00478
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010410719
• UDI-Public: 03596010410719
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• 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