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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for one (1) unknown helical blade. Initial implant date reported as 5 weeks ago (exact date is unknown). Device is not expected to be returned for manufacturer review/investigation. (b)(6). (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient was initially implanted with titanium trochanteric fixation nail advanced (tfna). The initial surgery was performed 5 weeks ago. On an unknown postoperative date it was identified that the blade has been cut out. No information about patient outcome. Concomitant medical products: lag screw (part # unknown, lot # unknown, quantity: 1), nail (part # unknown, lot # unknown, quantity: 1), distal screw (part # unknown, lot # unknown, quantity: 1). This report is for one (1) unknown helical blade. This is report 1 of 1 for (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6149598
MDR Text Key61591458
Report Number2520274-2016-15600
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
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: 12/06/2016 Patient Sequence Number: 1
Treatment
ONE (1) DISTAL SCREW (PART # UNKNOWN); ONE (1) LAG SCREW (PART# UNKNOWN); ONE (1) NAIL (PART # UNKNOWN)
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