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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.390S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Date of event is an unknown date in 2022. Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. Manufacturing location: (b)(4) / packaged, sterilized and released by: monument manufacturing date: july 22, 2021. Expiration date: july 01, 2031. Part: 04. 038. 390s, tfna fenestrated helical blade 90mm -sterile. Lot: 270p543 (sterile). Note: helical blade was manufactured by (b)(4); lots 239p793 / 252p897. Parts were packaged, sterilized, and released by monument. Production order traveler met all inspection acceptance criteria. Packaging label log (pll) was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. Sterilization control number (scn) supplied by (b)(4) was reviewed and determined to be conforming. This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Product was not returned. Based on the information available, it has been determined that no corrective and 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent osteosynthesis for fracture of the trochanteric femur with the trochanteric fixation nail advanced (tfna) system and augmentation. The surgeon exfoliated the iliofemoral ligament and performed extramedullary reduction with a custom-made elevator. The surgeon inserted the tfna nail, the blade, and the cement. The surgery was completed successfully without any surgical delay. The patient started to load-bear from the day after surgery; postoperative x-rays showed no defects. Postoperative x-rays taken on (b)(6) 2022, also showed no defects. On (b)(6) 2022, the patient was walking on their own and was moved to a nursing facility. The patient complained of pain. Cut-out was confirmed on (b)(6) 2022. Circumstances are unknown however, there is a possibility that patient may have fallen, as there are symptoms of a fall on the patient¿s face and other parts of the body. The patient denies having fallen. This report is for a tfna fenestrated helical blade 90mm - sterile. This is report 2 of 3 for (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 90MM - STERILE
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14058893
MDR Text Key291820859
Report Number8030965-2022-02335
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.390S
Device Lot Number270P543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
Treatment
TFNA FEM NAIL Ø11 125° L200 TIMO15; UNK - BIOMATERIAL - CEMENT: TRAUMACEM
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