MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,4.0 EP-1,DSPL BL; SAW, POWERED, AND ACCESSORIES

Model Number 7205326

Device Problems Melted (1385); Overheating of Device (1437)

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

Event Date 11/10/2017

Event Type  malfunction  

Event Description

It was reported that when used a probe during a surgery, found the part of probe approaching the handle shank melted.Then three probes with same lot number were used to the surgery, but similar problems occurred.Total 4 probes failed and were overheating.Finally a different lot number same code number device was used to complete the surgery.No patient injury was reported.

Manufacturer Narrative

Four 7205326 4.0mm ep-1 disposable acromionizer blades were reported on.Two were returned.The complaint allegation says: ¿the initial blade handle shank melted¿three more probes used with similar problems.Total four probes failed and were overheating¿.This occurred during surgery.One device is in good condition.It spins freely.The second device is seized up, has clearly over heated and is melted.Returns for these symptoms have been found to be consistent with the device being used with insufficient irrigation.The device is not intended to be engaged without suction either.Per the ifu: ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.¿ and it also states: ¿irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ the device was tested and found to run normally.

• Brand Name: ACROMIONIZER,4.0 EP-1,DSPL BL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7061605
• MDR Text Key: 93219102
• Report Number: 1219602-2017-01483
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)220324(10)50654918
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: 50654918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1