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

Model Number	7205326
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking.A backup device was available to complete the procedure with no patient injuries.Per customer¿s response the device ran continously.
Additional Manufacturer Narrative
One 7205326 4.0mm ep-1 disposable acromionizer blade returned.The complaint allegation stated: ¿it was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking.A backup device was available to complete the procedure with no patient injuries.Per customer¿s response the device ran continuously.¿ the blade was tested with a dyonics handset and showed no irregularities.The device produced a typical whirring sound of the inner blade rotations.The complaint could not be duplicated.It could have been temporary difficulty with excising of tissue and bone fragments.Returns of this nature have been found to be consistent with the device being ¿tested¿ with insufficient or without irrigation and suction.No root cause related to the manufacturing of this device was established.

• 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: 7526697
• Report Number: 1219602-2018-00611
• Device Sequence Number: 1121768
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)220203(10)50645208
• 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
• Report Date (Section B): 06/13/2018

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: 02/03/2022
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: 50645208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1