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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7210976
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2018
Event Type  malfunction  
Event Description
It was reported that 90 seconds after starting meniscal resection, metal debris occurred in the joint. A backup device was available to complete the procedure with no patient injuries.
 
Manufacturer Narrative
The reported incisor plus elite blade, intended for use in treatment, was not returned for evaluation. A relationship between the product and reported incident cannot be established as the product was not returned. Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed. From the information provided, the blade shed during use, causing metal debris to enter the joint space. An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive "side-loading" on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
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Brand NameINCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
Type of DeviceSAW, 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
5123585706
MDR Report Key7807067
MDR Text Key118093685
Report Number1219602-2018-01098
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7210976
Device Catalogue Number7210976
Device Lot Number50708552
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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