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 Information (3190)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a procedure the device was not working.A backup device was not available.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the product and no issue was observed.A functional evaluation revealed the head assembly was making a noise and sticking.Disassembly revealed the instrument had a cracked lohet and the threads on the body were damaged.The complaint was confirmed and the root cause has been determined to be expected wear/tear due to usage and time in the field.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: SVCE REPL, SAGITTAL SAW 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 w william cannon dr.; austin, TX 78735
• MDR Report Key: 6518736
• MDR Text Key: 73813186
• Report Number: 3003604053-2017-00050
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• 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