MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIOBLASTER,5.5MM,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 7205669

Device Problem Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

International zip code: (b)(6).

Event Description

It was reported that during a subacromial decompression procedure, there was metal debris in the joint.The blade was inspected and scarring at the proximal end of the inner blade was found.Backup device was available to complete the procedure.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 7205669 acromioblaster, 5.5mm,ep-1,dspl blade, intended for use in treatment, has been returned for evaluation.Visual assessment showed abrasion on the burr confirming the shedding/flaking as reported.The device has been bent.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.The instruction for uses states: ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: ACROMIOBLASTER,5.5MM,EP-1,DSPL BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9526918
• MDR Text Key: 173802103
• Report Number: 1219602-2019-01650
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010293077
• UDI-Public: 03596010293077
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Model Number: 7205669
• Device Catalogue Number: 7205669
• Device Lot Number: 50787224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1