MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 4.0 ELITE ABRADER 6/BX; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200722
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a foot joint surgery, the tip of the "4.0mm elite abrader blade" came off immediately after opening the package.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
¿h10 h3, h6: the reported 4.0 mm elite abrader burr, used in treatment, was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The condition of the returned product does not match the condition of a new product.The product had visible gall marks along the inner side of the outer burr sheath, and the burr head was worn down, indicating side-loading of the product and contact between the burr and sheath during use.The burr component, which was separated from the body of the inner assembly, had actually separated from itself.The remaining tail end of the burr component could be seen within the inner assembly tube; the weld was intact.The metal burr component had been broken off below the weld.Ifu pn 1060595 rev w states ¿do not allow the rotating portion of any blade or burr to touch any metallic object damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo¿ / ¿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.¿ there is evidence that the device was used.The conditions observed are consistent with the effects warned against in the ifu when the device instructions are not followed.A review of the manufacturing and complaint records was performed for this lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BLADE 4.0 ELITE ABRADER 6/BX
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10135935
• Report Number: 1219602-2020-00864
• Device Sequence Number: 3426797
• Product Code: HAB
• UDI-Device Identifier: 03596010578006
• UDI-Public: 3596010578006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 02/15/2023
• Device Catalogue Number: 72200722
• Device Lot Number: 50715063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1