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

Model Number 7205687

Device Problem Break (1069)

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

Event Date 01/03/2018

Event Type  malfunction  

Event Description

It was reported that the tip of the blade broke during use.No patient injury reported.

Manufacturer Narrative

One single 7205687 orbit incisor plus ep-1 blade returned.This device is sold as a box of six which is one product item sold.They are not intended for individual sale.The blade is used.The complaint said: ¿it was reported that the tip of the blade broke during use¿.There is obvious damage to the device.It has been totally disassembled.It is unknown whether the device was previously separated in attempt to get it functioning.The tip of the inner blade has been fractured.The middle blade is sprung at the flex keyway machined area.The teflon sheath has been ripped.The inner blade tip has been ripped off.The cup is stuck inside the outer blade cup.The outer cup most distal edge has attained damage from either force or contact with another instrument or device.This device has been used in an aggressive manner and the symptoms indicate force has factored into the damage attained.Ifu says: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device¿.No root cause related to the manufacture of this device can be determined.Device returned for evaluation.Device evaluated by the manufacturer.

• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7226414
• MDR Text Key: 98643016
• Report Number: 1219602-2018-00143
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010373229
• UDI-Public: (01)03596010373229(17)210812(10)50615767
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: 7205687
• Device Catalogue Number: 7205687
• Device Lot Number: 50615767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1