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

Catalog Number	7205326
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 7205326 disposable acromionizer 4.0 ep-1 blade used for treatment, was returned for evaluation.The complaint stated: ¿before when the package was opened, it was found the product end broken.¿ the device was received damaged and used.The inner and outer components had evidence of having become melted, seized up and subsequently broken and pieces separated.The inner blade handle was melted.A broken portion of the distal handle was absent.Returns for melted symptoms were found aligned with the product having been ¿tested¿ without or with insufficient irrigation.This device is not intended to be engaged without suction.Per instructions for use: ¿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.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ no root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that before when the package was opened, it was found the product end broken.No patient involved.Results of investigation have concluded that this unit was used in a surgery and the inner and outer components had evidence of having become melted, seized up and subsequently broken and pieces separated which makes it a re-portable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 9251081
• Report Number: 1219602-2019-01337
• Device Sequence Number: 11374827
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: 03596010251541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 05/14/2023
• Device Catalogue Number: 7205326
• Device Lot Number: 50735511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1