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

Model Number	7205327
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr rubs against the sheath.All fragments were removed from the patient.No patient injury was reported.There was no significant delay and back up was available to complete the procedure.
Additional Manufacturer Narrative
One 5.5 acromionizer burr was returned for evaluation.Visual assessment of the device identified a contact point on a section of the outer sheath at its distal end.The bronze bushing shows a contact point corresponding with the contact point on the sheath.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.

• 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: 7580850
• Report Number: 1219602-2018-00711
• Device Sequence Number: 1555751
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: (01)03596010251558(17)220419(10)50659783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 04/19/2022
• Device Model Number: 7205327
• Device Catalogue Number: 7205327
• Device Lot Number: 50659783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1