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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.014S
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Facility address reported as (b)(6). 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 (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, date due to a broken nail. A new trochanteric fixation nail advanced (tfna) was placed. Patient was originally treated for subtrochanteric/ intertrochanteric fracture right femur on (b)(6) 2021. Three weeks postoperatively, patient began to feel pain. Procedure was completed successfully. This report is for a 10mm/125 deg ti cann tfna 235mm/right ¿ sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/125 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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13518530
MDR Text Key287349467
Report Number8030965-2022-00857
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBE
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,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.014S
Device Lot Number204P757
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/11/2022 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
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