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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205311
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2018
Event Type  malfunction  
Event Description
It was reported that tiny specs of metal did grind out of the device into the joint. No patient injury or significant delay were reported. A back up was used to complete the procedure.
 
Manufacturer Narrative
Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device.
 
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Brand NameSYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE
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 Key7898989
MDR Text Key121458481
Report Number1219602-2018-01310
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAS
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 10/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205311
Device Catalogue Number7205311
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 Received10/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/15/2018
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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