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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,BOXED4.5 EP-1 SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SYNOVATOR BLADE,BOXED4.5 EP-1 SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205310
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that the device was shedding metal debris during an ankle arthroscopy. A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation. Thus, the complaint could not be verified and a root cause could not be determined with confidence. It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider. As such the complaint is being closed without conclusion. However, if the product is returned in the future the complaint can be reopened and evaluated.
 
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Brand NameSYNOVATOR BLADE,BOXED4.5 EP-1
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 Key8029004
MDR Text Key126015721
Report Number1219602-2018-01485
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUK
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 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205310
Device Lot Number50709446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2018
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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