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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH ROD, FIXATION, INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown. The 510k: this report is for an unknown tfna blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Unknown if/when the device was explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter phone number was not provided. Initial report is a synthes sales consultant. 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 post-operatively the trochanteric fixation nail anti-rotation (tfna) blade cut through the head of the femur. Concomitant reported part: tfna nail (part/lot unknown, quantity 1). This report is for an unknown tfna blade. This is report 1 of 1 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf
SZ
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7176142
MDR Text Key96779636
Report Number8030965-2018-50185
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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