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

Catalog Number	7205326
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the blade made a metallic noise when rotating and the metal flakes were shed from the blade.Even though the complainant confirmed that the metal flakes fell off outside the body, she said that this blade had been used in patient.There were no surgical delay or patient injuries.No backup device was available and according with the reporter, it is unknown if the procedure was completed.
Additional Manufacturer Narrative
One 7205326 disposable acromionizer 4.0 ep-1 blade used for treatment, was returned for evaluation.The complaint stated: ¿the blade made a metallic noise when rotating and the metal flakes were shed from the blade.¿ there are heavy rotational score bands present all up and down the outer diameter surface of the inner blade.This causes metal shavings during rotation.This leads to seizing.The reported conditions have been found consistent with lack of sufficient irrigation and side loading.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Make sure the hand piece is off while changing blade tip position.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.

• 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: 8603113
• Report Number: 1219602-2019-00545
• Device Sequence Number: 2294349
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 07/17/2023
• Device Catalogue Number: 7205326
• Device Lot Number: 50747319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1