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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfna nail/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(6). 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent surgery for femoral trochanteric fracture with trochanteric fixation nail advanced (tfna) along with a flexible driver. During the surgery, the surgeon tried to lock the tfna blade many times but couldn't connect the driver to the device properly. The surgeon made an extra incision (about 10cm) and adducted the affected leg as far as possible to lock the devices. The procedure was completed successfully with less than thirty (30) minutes delay. Patient was stable. Concomitant devices: tfna blade (part: unknown, lot: unknown, quantity: 1). This report is for an unknown tfna nail. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - NAILS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9714513
MDR Text Key191230950
Report Number8030965-2020-01161
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 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
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 Received02/21/2020
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: 02/14/2020 Patient Sequence Number: 1
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