MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205327
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder sad, the burr seemed to bind up at the blue hub and blue; shavings from the plastic came up from the hub and into the joint,.Metal fragments were cleaned out from the joint by flushing.A back-up device was available to complete the procedure with neither delay nor patient injuries.
Additional Manufacturer Narrative
One used 5.5 mm acromioblaster burr was returned for evaluation.Visual assessment of the device showed the polycarbonate components, the sluff chamber and adapter body are melted causing the reported seizing and shedding.This condition indicates the burr was operated with improper fluid flow.No root cause related to the manufacture of the device can be established.

• Brand Name: ACROMIONIZER,5.5,EP-1,DSPL BL(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8149402
• Report Number: 1219602-2018-01705
• Device Sequence Number: 1771192
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: 03596010251558
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 08/12/2023
• Device Catalogue Number: 7205327
• Device Lot Number: 50752614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1