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

Catalog Number 7205786S

Device Problem Electrical Shorting (2926)

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

Event Date 02/28/2018

Event Type  malfunction  

Event Description

It was reported that the device shorted.No case or patient injures were 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 it was reported that the instrument did not run.Further troubleshooting found the lohet had become loose which caused the unit to not function.The complaint of shorting out was not confirmed as the complaint could not be duplicated.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.

• Brand Name: SVCE REPL, SAGITTAL SAW POWER
• 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: 7369753
• MDR Text Key: 103588862
• Report Number: 1643264-2018-00245
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010454843
• UDI-Public: (01)03596010454843
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205786S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• 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