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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown tfna helical blade/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent open reduction internal fixation surgery for femoral trochanteric fracture with a trochanteric fixation nail advanced (tfna) system. During the surgery, the surgeon reduced the fracture and implanted the tfna implants. It seemed that there was a gap, but the surgeon thought that the bone contact was good, and the surgery was completed successfully without any surgical delay. Just after the surgery, the surgeon confirmed by x-rays that there was no problem. On (b)(6) 2020 the surgeon confirmed by ct scan that there was a gap of about 2cm between implant and bone. The surgeon commented that it was possible that not enough reduction caused this event. After following up with the patient surgeon will decide whether to perform the revision surgery or not. Patient outcome is reported as stable. No further information is available. Concomitant devices reported: 10mm/125 deg ti cann tfna 200mm - sterile (part # 04. 037. 013s, lot # unknown, quantity 1); locking screw (part # unknown, lot # unknown, quantity unknown). This report is for one (1) unknown tfna helical blade. This is report 2 of 3 for complaint (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
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 Key10793352
MDR Text Key217347740
Report Number8030965-2020-08652
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 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received10/09/2020
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: 11/05/2020 Patient Sequence Number: 1
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