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

Catalog Number 7205785S

Device Problem Electrical Shorting (2926)

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

Event Date 11/20/2017

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The device was received and sent to the oem (original equipment manufacturer) for evaluation.There was no relationship found between the returned device and the reported incident.An evaluation was performed by the oem and no visual deficiencies were reported.A functional evaluation was performed by the oem and the device was tested and passed all test.The oem could not duplicate the problem.Device was disassembled and found no problem with any of the parts.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.

• Brand Name: SERVICE, REPL, DRILL, POWER
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7052741
• MDR Text Key: 92989291
• Report Number: 3003604053-2017-00327
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010454836
• UDI-Public: (01)03596010454836
• 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: 02/12/2018

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 Catalogue Number: 7205785S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/12/2018
• 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