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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES, USA TI RIB HOOK
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SYNTHES, USA TI RIB HOOK Back to Search Results
Catalog Number 04.641.001
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2013
Event Type  malfunction  
Event Description
Device report from synthes (b)(4) reports and event in (b)(6) as follows: during a surgery with exchange of magnetic rods and veptr ii rib hooks, the surgeon attempted to place the rib hook in the patient and connect it with the rib hook cap.It was reported that the rib hook bent itself, the surgeon replaced it and the hook broke into two pieces when cleaned after surgery.This report is 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Device used for treatment not diagnosis.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Placeholder.
 
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Brand Name
TI RIB HOOK
Manufacturer (Section D)
SYNTHES, USA
west chester PA
Manufacturer Contact
griselda webster
1302 wrights lane east
west chester, PA 19380
8006207025
MDR Report Key3556521
MDR Text Key4048996
Report Number2520274-2013-07975
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
H030009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/16/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.641.001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
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