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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.113S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Date of event is an unknown date in 2022. Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. Part: 04. 037. 113s synthes lot: 9958726, supplier lot: n/a, release to warehouse date: december 14, 2015 expiration date: december 01, 2025 manufacturing location: (b)(6). No nonconformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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, and (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 11mm/125 degree titanium (ti) cannulated tfna nail. This is report 1 of 3 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TFNA 200MM - 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 Key14058714
MDR Text Key288996621
Report Number8030965-2022-02332
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 Number04.037.113S
Device Lot Number9958726
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 Manufactured12/14/2015
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 HELICAL BLADE PERF L90 TAN; UNK - BIOMATERIAL - CEMENT: TRAUMACEM
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