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

Catalog Number 7205786S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/02/2014

Event Type  malfunction  

Event Description

It was reported that the device is not reciprocating.

• 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: james gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6994892
• MDR Text Key: 91299706
• Report Number: 1643264-2017-01354
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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?: No
• Date Manufacturer Received: 04/02/2014
• Type of Device Usage: N
• Patient Sequence Number: 1