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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC FERRIS-SMITH SYMMETRY RONGEUR, IVD

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SYMMETRY SURGICAL INC FERRIS-SMITH SYMMETRY RONGEUR, IVD Back to Search Results
Model Number 53-1160
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
Based on the date code etched on the device, this instrument was manufactured sometime in 1986. The instrument also shows signs of wear consistent with use for a long period of time. Based on the age and condition of the returned instrument, it was determined that the root cause of the failure is normal wear and tear.
 
Event Description
Patient was hospitalized for the management of a herniated disc l5-s1. At the discectomy, the end of the clamp broke, a piece was identified at the disc level. After several attempts the remaining piece could be removed.
 
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Brand NameFERRIS-SMITH
Type of DeviceSYMMETRY RONGEUR, IVD
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
victoria rogers
3034 owen drive
antioch, TN 37013
8002513000
MDR Report Key7405206
MDR Text Key105236301
Report Number3007208013-2018-00004
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1160
Device Catalogue Number53-1160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1986
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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