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

Model Number	7205326
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7061607
• Report Number: 1219602-2017-01482
• Device Sequence Number: 782994
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)220324(10)50654918
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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
• Operator of Device: 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: 12/07/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1