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

Catalog Number 7205558

Device Problem Break (1069)

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

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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.
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6555080
• MDR Text Key: 74897503
• Report Number: 1219602-2017-00485
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010252579
• UDI-Public: (01)03596010252579(17)181031(10)50763632
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1