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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH RFNA / 10 / 320 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH RFNA / 10 / 320 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.233.032S
Device Problem Use of Device Problem (1670)
Patient Problem Physical Asymmetry (4573)
Event Date 08/14/2021
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. 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
It was reported that on (b)(6) 2021, a reduction was achieved on a femoral shaft fracture and retrograde femoral nailing system (rfna) displaced fracture because the radius of curvature is too great. Upon placement of the rfna, the reduction was lost, resulting in an apex anterior deformity because of the high radius of curvature of the nail, which needed to be removed and a retrograde/antegrade femoral nail (rafn) nail was used instead to fixate the fracture. Procedure was completed successfully with thirty(30) minutes surgical delay. This report is for one (1) rfna / 10mm / 320mm 5 degree bend / sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameRFNA / 10 / 320 5 DEG BEND / 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 Key12456388
MDR Text Key270914927
Report Number8030965-2021-07652
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.233.032S
Device Catalogue Number04.233.032S
Device Lot Number76P1909
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 Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2020
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: 09/10/2021 Patient Sequence Number: 1
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