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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.243S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Patient height reported as 175 centimeters. Complainant part is not expected to be returned for manufacturer review/investigation. Part 04. 037. 243s, lot 71p5923: manufacturing location: (b)(4). Manufacturing date: october 06, 2020. Expiration date: september 01, 2030. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 tfna nail. This is report 1 of 4 for (b)(4).
 
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Brand Name12MM/130 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)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14026446
MDR Text Key293168480
Report Number8030965-2022-02226
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 Number04.037.243S
Device Lot Number71P5923
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
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 END CAP EXTENS. 5 TAN; TFNA HELICAL BLADE L110 TAN
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