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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 LE 125° L340 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FEM NAIL Ø10 LE 125° L340 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.025S
Device Problem Break (1069)
Patient Problems Pain (1994); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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) tfna fem nail ø10 le 125° l340 timo15. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameTFNA FEM NAIL Ø10 LE 125° L340 TIMO15
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach CO 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13445080
MDR Text Key287909573
Report Number8030965-2022-00687
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
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
1 Device was Involved in the Event
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? Yes
Device Operator
Device Catalogue Number04.037.025S
Device Lot Number209P858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA.; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE.; UNK - SCREWS: NAIL DISTAL LOCKING.
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