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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code (b)(6).
 
Event Description
It was reported that the surgeon applied to much pressure on the product and the synovator blade cracked during the procedure. A backup device was available to complete the procedure with no delay or patient injuries reported.
 
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date. Additional information was received from customer to confirm that device did not break inside the patient therefore the event is not considerable reportable.
 
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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 Key8051625
MDR Text Key126647845
Report Number1219602-2018-01512
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeSF
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 12/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205310
Device Lot Number50689409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2017
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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