MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR,CONCAVE CRV,M.A.S.S.; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205558
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported the incisor concave curve device shaft broke.A back up device was utilized to complete the procedure.No patient injury or complications were reported.
Additional Manufacturer Narrative
Visual assessment of the blade confirmed the reported breakage.The inner blade has broken at the flex cut.The outer blade is slightly bent.The condition of the device indicates that an excessive side load was placed on the blade during use.No root cause related to the manufacturing process can be established.

• Brand Name: INCISOR,CONCAVE CRV,M.A.S.S.
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6555080
• Report Number: 1219602-2017-00485
• Device Sequence Number: 16318267
• Product Code: HAB
• UDI-Device Identifier: 03596010252579
• UDI-Public: (01)03596010252579(17)181031(10)50763632
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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 Catalogue Number: 7205558
• Device Lot Number: 50763632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1