MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP DYO PWR LG BATTERY OSC SAW; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 72204092S

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the motor runs automatically.No patient was involved.

Manufacturer Narrative

An evaluation was performed by the supplier and could confirm the customer complaint for the motor runs automatically.This device was shipped on (b)(6) 2015.Functional testing was performed and showed the instrument runs without the triggers being pressed.It was determined the motor was bad and the controller also failed for high current.This failure is caused from wear from use.No manufacturing related defects were observed.

• Brand Name: SERVICE REP DYO PWR LG BATTERY OSC SAW
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 7608557
• MDR Text Key: 111849595
• Report Number: 3003604053-2018-00096
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72204092S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• 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