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

Catalog Number 7205786S

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported a short circuit.No user injury was reported.

Manufacturer Narrative

The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A product evaluation was performed by smith & nephew.A visual inspection performed identified the arm retaining pin was missing.The activation arm is loose as a result of the missing pin.A functional test revealed the device worked with no problem found other than the loose activation arm.The complaint was not confirmed and the root cause could not be determined since the reported malfunction of an electrical short could not be duplicated during the product evaluation process.

• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7549728
• MDR Text Key: 109556183
• Report Number: 1643264-2018-00417
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

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: 7205786S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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