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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA .0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA .0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.032.100S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). Unknown if device is/not expected to be returned for manufacturer review/investigation. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that a patient developed an infection and underwent removal of hardware. A patient, who was implanted with a trochanteric fixation nail (tfn), presented with redness and swelling along the right hip. He was diagnosed with infection and underwent removal of tfn, a lag screw and two dual force screws on (b)(6) 2016. A culture was taken; results are pending and will not be available. It was noted that this was the patient's third procedure. There was no surgical delay. It was reported that the procedure was successfully completed. Patient outcome is unknown. There are no plans at this time to implant other devices. No additional information available. This report is 2 of 4 for (b)(4).
 
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Brand Name.0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5462370
MDR Text Key39078233
Report Number2520274-2016-11326
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK092646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.032.100S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/26/2016 Patient Sequence Number: 1
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