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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BOXED F/R,BL,4.5MM,SERIES 3000 /6 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7206011
Device Problems Material Fragmentation (1261); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the bonecutter blade produced small chips of metal in the joint. A backup device was available to complete the procedure with no significant delay or patient injuries reported.
 
Manufacturer Narrative
Visual assessment under magnification confirmed the plating and silicone that is applied appeared normal. The inner blade exhibited an abrasion at the tip along with a corresponding abrasion on the inner blade. The inner edge form appeared to have some damage to the cutting edge surface; this damage may have resulted from making contact with another object. The damage on the inner edgeform radius seems to have created an uneven surface that yielded some excess material that could be visually seen protruding above the cutting surface. The excess material appears to have made contact with the id of the outer edgeform which potentially created some galling/shedding between the two surfaces to occur. There was no friction felt during the functional spin test while the inner blade rotated freely within the outer blade in the unloaded condition. Per the evaluation that was performed based on the details that were provided, the investigation has confirmed that material has been displaced between the two surfaces (inner/outer edgeform) as described by the customer resulting in some material galling/shedding to occur. 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. A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review device labeling (including technique guides, ifus, etc. ) it was reported that the small metal chips from the blade were removed upon flushing the joint, and no patient harm or injury was sustained as a result. Based on the information provided, no additional risk to the patient is anticipated. No further medical assessment is warranted based on the information provided.
 
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Brand NameBOXED F/R,BL,4.5MM,SERIES 3000 /6
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 Key8100077
MDR Text Key128270460
Report Number1219602-2018-01619
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number7206011
Device Lot Number50724372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2018
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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