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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR

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SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1664
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The date of the event is unknown at this time. The tip that broke is being returned with the handle it was used with for evaluation. It was communicated that the surgeon would not change his technique of twisting and torquing the device which is a contraindication in the ifu. A follow-up will be submitted once we have evaluated the returned instruments.
 
Event Description
During a trial of the (b)(6) product, a peice of the cutting tip broke off and fell into the patient. The piece was removed with no harm to the patient.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
6159645290
MDR Report Key8910886
MDR Text Key155210420
Report Number3007208013-2019-00031
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number53-1664
Device Lot Number19B438CT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated by Manufacturer? Yes
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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