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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. ORBIT INCISOR PLUS,EP-1 (6/BX); SAW, POWERED, AND ACCESSORIES Back to Search Results
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.
 
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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 Key7226414
MDR Text Key98643016
Report Number1219602-2018-00143
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010373229
UDI-Public(01)03596010373229(17)210812(10)50615767
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Date08/12/2021
Device Model Number7205687
Device Catalogue Number7205687
Device Lot Number50615767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/03/2018
Initial Date FDA Received01/29/2018
Supplement Dates Manufacturer Received02/01/2018
Supplement Dates FDA Received02/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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