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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA HELICAL BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.295S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 02/01/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. A review of the device history record has been completed. 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
It was reported that on (b)(6) 2019, the patient underwent surgery for trochanteric fracture of femur with tfna. After surgery, on unknown date, the patient fell. In early (b)(6) 2022, when the patient visited the hospital because of pain due to fall, an x-ray was taken, and the cut-out was found. However, the patient had dementia and it was unknown if the cut-out occurred when the patient fell or for any other reason. On (b)(6) 2022, the removal surgery of tfna was performed. The removal surgery was completed successfully with no surgical delay. Since the patient is a wheelchair user, and in the future, conservative treatment will be kept if the patient does not have pain, and tha will be performed if the patient has pain. No further information is available. This complaint involves one (1) device tfna helical blade l95 tan. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameTFNA HELICAL BLADE L95 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13669063
MDR Text Key290567132
Report Number8030965-2022-01380
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.038.295S
Device Lot NumberH713605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2018
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
Treatment
TFNA FEM NAIL Ø12 130° L170 TIMO15; UNK - SCREWS: NAIL DISTAL LOCKING
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