MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORBIT INCISOR PLUS,EP-1 (6/BX); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205687

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2016

Event Type  malfunction  

Event Description

It was reported that the blade broke at the tip during use.The broken pieces were completely removed from the surgical site and the procedure was successfully completed using a back-up device.No patient injury or other 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 bent indicating side loading took place.No root cause related to the manufacture of the device can be established, and is likely to be attributed to user error.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.

• Brand Name: ORBIT INCISOR PLUS,EP-1 (6/BX)
• 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 ; 150 minuteman rd; amdover, MA 01810 ; 5123585706
• MDR Report Key: 6003065
• MDR Text Key: 57262603
• Report Number: 1219602-2016-01154
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Catalogue Number: 7205687
• Device Lot Number: 50599483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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