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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN 10X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN 10X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1851-1036S
Device Problem Fracture (1260)
Patient Problems Fall (1848); Failure of Implant (1924); Limb Fracture (4518)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
"it was reported via medwatch # (b)(4): "on (b)(6) 2020, patient sustained injury while playing on monkey bars at school. Fell sustaining a per-prosthetic right proximal femur fracture. Fracture was immediately distal to the retained femoral plate. Patient brought to the operating room the next day and underwent removal of blade plate implant and screws, right proximal femur and open reduction of right proximal femur fracture with insertion of intramedullary nail with proximal and distal locking screws. Discharged next day. Patient doing well until one month later. Patient was shooting baskets at school when he felt a pop in his right leg and immediately fell and had significant pain. X-rays showed fractured intramedullary nail through the distal of the 2 proximal locking screw holes. The rod broke in that position, but the bone gave way through the previous area of fracture. After a plan was made to remove the broken femoral nail and then treat the fracture with a standard adult blade plate and appropriate implants and equipment were obtained, patient was brought to the operating room to undergo removal of the broken implant and fixation of his right proximal femur fracture with a fixed angle blade plate. Patient did well and returned to recovery in stable condition. Remains inpatient without incident. " additionally reported: "patient does have developmental dysplasia of the hip and type i diabetes, along with charcot-marie-tooth. ".
 
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Brand NameFEMORAL NAIL, RIGHT T2 GTN 10X360 MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11076840
MDR Text Key223772928
Report Number0009610622-2020-01060
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1851-1036S
Device Catalogue Number18511036S
Device Lot NumberK092880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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