MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6); SAW, POWERED, AND ACCESSORIES

Model Number	7205345
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dsaver blade broken in rotation in the joint during ask.No patient injury was reported.
Additional Manufacturer Narrative
One 7205345 4.5mm boxed incisor plus blade reported on.One single blade was returned.These are sold as a box of six devices.They are not intended to be sold individually.There are heavy rotational score bands present on the outer diameter of the inner blade.Spin test produces drag from bowing.Shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.Per ifu precautions: ¿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¿.No root cause related to the manufacturing of the device was established.Use error may have been a contributing factor to the event.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Complaint history search revealed no additional complaints for this production lot.
Event or Problem Description
It was reported that the shaver blade broke during rotation in the joint during ask procedure.Broken pieces were removed from the patient.A backup device was available to complete the procedure with no major delay or patient injuries.

• Brand Name: BOXED INCISOR PLUS BL,(BX6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7251892
• Report Number: 1219602-2018-00200
• Device Sequence Number: 1022795
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: (01)03596010251688(17)220606(10)50668052
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: 06/06/2022
• Device Model Number: 7205345
• Device Catalogue Number: 7205345
• Device Lot Number: 50668052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1