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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 Problems Misassembled (1398); Malposition of Device (2616); Misassembly by Users (3133)
Patient Problem No Code Available (3191)
Event Date 01/22/2018
Event Type  Injury  
Manufacturer Narrative
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
Concomitant device reported: pfna ii nail (472. 103s, lot number unknown, quantity 1).
 
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. The device is an instrument. Complainant part has not been returned for manufacturer review/investigation. 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. Patient experienced a surgical delay. 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
The reported devices were used in surgery for femoral trochanteric fracture on (b)(6) 2018. After the implants were inserted and the incision site was closed, the surgeon found that the blade was inserted incorrectly through the nail under an x-ray image. The blade was replaced with a new one, and it took 20 minutes to finish the revision surgery. The surgeon commented that he did not properly assemble an aiming arm to the other instruments by mistake. There was an additional 60 minute delay for this patient¿s surgery. This complaint involves 3 parts. This is report 2 of 3 for (b)(4). This report is for an aiming arm. This complaint involves one (1) device.
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7259528
MDR Text Key115273885
Report Number8030965-2018-50991
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,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/09/2018 Patient Sequence Number: 1
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