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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.244S
Device Problem Fracture (1260)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported a patient who had a trochanteric fixation nail advanced (tfna) had a fractured. A revision surgery occurred. Original implant date was (b)(6) 2021. Explant date was (b)(6) 2022. Patient deceased post revision surgery. This is report 1 of 1 for (b)(4). This report is for a tfna nail.
 
Manufacturer Narrative
Additional narrative: unknown when fracture occurred. 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 history: part #: 04. 037. 244s; lot #: 57p0049. Manufacturing site: (b)(6). Supplier: (b)(6). Release to warehouse date: (b)(6) 2020. Expiration date: 01 may 2030. No code available is for injury, revision surgery and death. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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.
 
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Brand Name12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14218869
MDR Text Key290163564
Report Number8030965-2022-02733
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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 Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.037.244S
Device Lot Number57P0049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEM: TFNA LAG SCREW.; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE.; UNK - SCREWS: NAIL DISTAL LOCKING.
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