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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI END CAP FOR TFNA 5MM EXTN - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TI END CAP FOR TFNA 5MM EXTN - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.005S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Malunion of Bone (4529)
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. Patient height reported as (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. Part: 04. 038. 005s; lot: 42p9455; manufacturing location: (b)(4). Manufacturing date: march 31, 2020. Expiration date: march 01, 2030. A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified. 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 on (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) with the trochanteric fixation nail advanced (tfna) system for the fracture of the trochanteric femur. The fracture was intramedullary, and the proximal fragment displaced posteriorly. The surgeon tried to reduce the fracture; however, it did not go well, and the fracture was fixed with subtype n (ikuta classification). The surgery was completed without any surgical delay. Intramedullary fixation was observed a few days after the surgery. Recently, the patient complained of pain, and it was confirmed that the pseudoarthrosis occurred. The revision surgery for removal of the implants and the total hip arthroplasty was performed on (b)(6) 2022. This report is for a locking screw. This is report 4 of 4 for (b)(4).
 
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Brand NameTI END CAP FOR TFNA 5MM EXTN - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14026924
MDR Text Key291818884
Report Number8030965-2022-02230
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 Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.038.005S
Device Lot Number42P9455
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/06/2022 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L36 F/NAILS TAN; TFNA FEM NAIL Ø12 130° L200 TIMO15; TFNA HELICAL BLADE L110 TAN
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