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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X340MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X340MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3425-3340S
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bone Fracture(s) (1870); Iatrogenic Source (2498)
Event Date 05/24/2020
Event Type  Injury  
Manufacturer Narrative
The reported event that long nail kit r1. 5, ti, right gamma3® ø13x340mm x 125° was alleged of issue ¿user related event - not product related¿ could be confirmed with the help of information provided by the sales representative. A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. No indications of material, manufacturing or design related problems were found during the investigation. A review of the labeling did not indicate any abnormalities. Based on the investigation, the root cause of the failure is user related as the user inserted a right nail into a left femur which is an off-label use. It has also been stated in warning and precautions section in ifu as ¿4. 2 intra-operative implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes. Select the required version carefully. ¿ for the surgeon to choose the required version carefully. If the product is returned or any additional information is provided, the investigation will be reassessed. Device disposition is unknown.
 
Event Description
As reported: (b)(6) hospital was doing a gamma nail and inserted a right nail into a left femur. Due to the bow in the nail, the nail fractured the distal anterior cortex of the pt's femur busting out through the bone. Not knowing what caused this to occur, the surgeon opened a longer nail to try and by-pass this newly created fracture but this too was a right (wrong sided) nail and the same issue occurred with the nail going through the same distal anterior fracture. It was at this time they had realised the wrong sided nails were used both times. It was not long after this i arrived at the hospital. Surgical delay of approx 60 minutes.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 13X340MM X 125
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10176359
MDR Text Key198537943
Report Number0009610622-2020-00295
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3425-3340S
Device Catalogue Number34253340S
Device Lot NumberK055C93
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 Received05/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2018
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: 06/19/2020 Patient Sequence Number: 1
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