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	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr rubbed against the metal outer tube.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
Device inspection showed few faint lengthwise scratches on the outer surface of the outer blade.This could indicate some contact with another device or instrument.Investigator tested the blade with a dyonics handset and showed no irregularities.The blade spins freely with no binding.The device did not produce shedding upon receipt.There are no other observations that would contribute to the complaint issue.There is no skiving on the outer diameter of the inner blade surface.There are dings and small gouges on the spherical blade surfaces.This could have produced a small amount of loose material.Temporary difficulty with excision of tissue and bone fragments may cause internal rubbing until cleared.There are no other observations that would contribute to the complaint issue.The symptom reported could not be replicated.No root cause related to the manufacturing of this device was 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: 7534382
• Report Number: 1219602-2018-00634
• Device Sequence Number: 2018849
• Product Code: HAB
• UDI-Device Identifier: 03596010251558
• UDI-Public: (01)03596010251558(17)220419(10)50659783
• 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: 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: 06/07/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/22/2018
• 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