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U.S. Department of Health and Human Services

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

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SYNTHES 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 Problems Pain (1994); Physical Asymmetry (4573)
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent the open reduction internal fixation for the trochanteric fracture of the femur with the trochanteric fixation nail - advanced (tfna) long nail. After the surgery, the fixation was stable so that the patient was in rehabilitation, however pain occurred when he stepped on the clutch while driving. It was confirmed that the tfna long nail and the blade junction was fractured at the time of physician visit and bone healing had not been achieved. The patient underwent the revision surgery. The surgeon confirmed with x-rays, that there were no remnants of fractured implant in the body. The surgeon commented that it is assumed that the full load was applied to the implant, because of the loss of the inside calcar femoral. In the revision surgery, the fractured implant was completely removed and the fracture site was reduced, and the tfna was replaced with a lag screw. The surgeon added impaction to the fracture near the sub-trochanter and engaged it, and inserted two screws laterally to the distal bone. Procedure was completed successfully. The fixation is as stable as before, but the surgeon was concerned about the ability of the implant to withstand the load. This report is for one (1) unk - nail head elements: tfna helical blade. This is report 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
510k: this report is for an unk - nail head elements: 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. Reporter is a j&j employee. 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.
 
Manufacturer Narrative
510k: this report is for an unk - nail head elements: 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. Reporter is a j&j employee. 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, the patient underwent the open reduction internal fixation for the trochanteric fracture of the femur with the trochanteric fixation nail - advanced (tfna) long nail. After the surgery, the fixation was stable so that the patient was in rehabilitation, however pain occurred when he stepped on the clutch while driving. It was confirmed that the tfna long nail and the blade junction was fractured at the time of physician visit and bone healing had not been achieved. The patient underwent the revision surgery. The surgeon confirmed with x-rays, that there were no remnants of fractured implant in the body. The surgeon commented that it is assumed that the full load was applied to the implant, because of the loss of the inside calcar femoral. In the revision surgery, the fractured implant was completely removed and the fracture site was reduced, and the tfna was replaced with a lag screw. The surgeon added impaction to the fracture near the sub-trochanter and engaged it, and inserted two screws laterally to the distal bone. Procedure was completed successfully. The fixation is as stable as before, but the surgeon was concerned about the ability of the implant to withstand the load. This report is for one (1) unk - nail head elements: tfna helical blade. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13445066
MDR Text Key285327424
Report Number8030965-2022-00686
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
Treatment
TFNA FEM NAIL Ø10 LE 125° L340 TIMO15; UNK - END CAPS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING
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