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

Model Number 7205785

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/27/2017

Event Type  malfunction  

Event Description

It was reported that the device had a short.No patient injury reported.

Manufacturer Narrative

The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product it was observed that a cable connecting socket had a broken cable prong lodged in it and the surrounding area was damaged.A functional evaluation could not be performed due to the broken cable prong lodged in the connecting socket.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the event include excessive force, misalignment, or twisting of the connector during connection/disconnection to a control unit.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.

• Brand Name: DYONICS POWER DRILL
• 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
• MDR Report Key: 7228237
• MDR Text Key: 98681412
• Report Number: 1643264-2018-00087
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010410702
• UDI-Public: (01)03596010410702
• 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
• Report Date: 03/22/2018

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 Model Number: 7205785
• Device Catalogue Number: 7205785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 03/22/2018
• 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: Reuse
• Patient Sequence Number: 1