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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAFEWIRE LLC YWIRE

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SAFEWIRE LLC YWIRE Back to Search Results
Model Number YWIRE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/30/2010
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Their request is for all device / patient complaints to have a mdr completed.According to safewire procedures this complaint didn't warrant a mdr to be completed as it didn't impact the patient by surgical intervention, death or serious injury.
 
Event Description
Pedicle screw case - upon conclusion of the procedure it was found that the end of the ywire had broken off.This device part of lot 292-10 item 145ba22-4.The broken piece of ywire was no more then 5mm in length and no evasive procedure took place took place to remove the broken wire.
 
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Brand Name
YWIRE
Type of Device
YWIRE
Manufacturer (Section D)
SAFEWIRE LLC
8963 stiriling rd
suite 7
cooper city FL 33328
Manufacturer (Section G)
SAFEWIRE LLC
8963 stiriling rd
suite 7
cooper city FL 33328
Manufacturer Contact
stephen inglese
8963 stirling rd
suite 7
cooper city, FL 33328
8002869155
MDR Report Key5489812
MDR Text Key40243757
Report Number3008595221-2015-00001
Device Sequence Number1
Product Code HXI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K 140576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 11/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/01/2011
Device Model NumberYWIRE
Device Catalogue Number145BA22-4
Device Lot Number292-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/30/2010
Device Age3 MO
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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