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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 Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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. (b)(4). 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) 2021 during a follow-up examination the x-ray showed a cutting out with dislocated femoral neck screw of the right trochanteric fixation nail advanced (tfna) with a protrusion of approximately 2. 0 cm over the countercorticalis into the acetabulum after a right pertrochanteric femur fracture. This was not preceded by trauma. On (b)(6) 2021 the tfna nail was removed and an acetabular floorplasty with cancellous bone grafting (own femoral head), implantation of a modular cementless hip prosthesis (mutars) and cerclages was performed. This report is for one (1) 12mm/130 deg ti cann tfna 200mm - sterile. This is report 1 of 3 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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12522189
MDR Text Key273012784
Report Number8030965-2021-07960
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.243S
Device Lot Number106P289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA HELICAL BLADE PERF L105 TAN
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