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	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the device overheated.There was a backup device available.No delay or patient injury was reported.
Additional Manufacturer Narrative
One 4.0 mm acromioblaster burr was returned for evaluation.Visual assessment of the device showed no damage/melting of the polycarbonate components that would indicate the device heated up.In addition the inner burr and outer sheath showed no evidence of being heated up.Functional inspection was performed and the inner burr rotated freely within the outer sheath as intended.The condition of a blade or burr heating up is the direct result of improper fluid flow during use.Per the device instructions for use under warnings ¿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.There were no indications that would suggest that the device did not meet product specifications upon release into 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: 8920322
• Report Number: 1219602-2019-01000
• Device Sequence Number: 14010678
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: 03596010251541
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 10/11/2023
• Device Catalogue Number: 7205326
• Device Lot Number: 50764065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1