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 Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that when the burr was switched on, it was very noisy, grating and scraping.No patient injury.
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event, this report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.After testing was performed smith and nephew was aware that the failure mode is not shedding or flaking, further investigation was also performed on the device and we came to the conclusion that this condition have been found to be consistent with the device being "tested" without or with insufficient irrigation.The device is not intended to be engaged without suction either.This "testing" condition means that the device was activated outside the patient.
Additional Manufacturer Narrative
Two 7205327 disposable 5.5mm ep-1 acromionizer blades returned.The complaint allegation states: "it was reported that when the burr was switched on, it was very noisy, grating and scraping.No patient injury." the first blade has a melted sluff chamber.Returns for this condition have been found to be consistent with the device being "tested" without or with insufficient irrigation.The device is not intended to be engaged without suction either.Per the ifu: "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." and it also states: "irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry)." the second device had no fault or failure observed.It shows no damage or signs of misuse.The blade was tested with a dyonics handset and showed no irregularities.The blade spins freely with no binding.There are no other observations that would contribute to the complaint issue for this blade.No root cause related to the manufacturing of this device was established.No further investigation at this time.

• 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: 7613813
• Report Number: 1219602-2018-00764
• Device Sequence Number: 1133965
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: (01)03596010251558(17)220929(10)50688511
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/14/2018

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: No Information
• Device Expiration Date: 09/29/2022
• Device Model Number: 7205327
• Device Catalogue Number: 7205327
• Device Lot Number: 50688511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 07/13/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/16/2018; 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1