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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR EP-1 4.5 ORBIT DSPL BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SYNOVATOR EP-1 4.5 ORBIT DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205321
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that when unpacking the synovator blade, it was found to have contamination on the tip. No case reported, therefore, there was no patient involvement. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSYNOVATOR EP-1 4.5 ORBIT DSPL BLADE
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10972971
MDR Text Key220688956
Report Number1219602-2020-02011
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 foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205321
Device Catalogue Number7205321
Device Lot Number50854343
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 Received01/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/30/2020
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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