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

Model Number	7205669
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9526918
• Report Number: 1219602-2019-01650
• Device Sequence Number: 10862489
• Product Code: HAB
• UDI-Device Identifier: 03596010293077
• UDI-Public: 03596010293077
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/24/2020

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: 02/13/2024
• Device Model Number: 7205669
• Device Catalogue Number: 7205669
• Device Lot Number: 50787224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1