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

Model Number	7205668
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (b)(4) disposable 4.0mm acromionizer ep-1 blade returned.The complaint indicated: ¿plastic on burr melted¿.This product is almost one year old.It does not show signs of use.The product is seized up, has become over heated and the sluff chamber area has been melted.Returns for grinding/noisy/screeching and melting symptoms have been found to be consistent with the device being ¿tested¿ or run 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).¿ root cause related to the manufacture of the device was not confirmed.
Event or Problem Description
It was reported that the plastic on burr melted, it was informed that the surgeon was using the burr in an open situation.No patient injury reported.

• Brand Name: ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7178280
• Report Number: 1219602-2018-00050
• Device Sequence Number: 164159
• Product Code: HAB
• UDI-Device Identifier: 03596010293084
• UDI-Public: (01)03596010293084(17)220206(10)50645383
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 06/02/2022
• Device Model Number: 7205668
• Device Catalogue Number: 7205668
• Device Lot Number: 50645383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial 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