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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, LEFT GAMMA3® Ø10X260MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X260MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 35250260S
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 06/10/2019
Event Type  Injury  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
Before the operation, confirmed the implant size while looking at the x ray image with surgeon and sales rep.They chose long gamma nail, but it was mistaken right/left; should have selected a right, but chose left.Since it passed to the nurse and there was no opening check, it was confirmed that the nail penetrated the front of the bone when the op advanced and came to the side stop of the distal as it is.Because the tight bones are fragile, they decided that it should be long and relief should be changed to short to complete the procedure.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Based on event description, it can be concluded that the event was not caused by a deficiency of the product; but rather the user.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.No indications of manufacturing or design related problems were found during the investigation.The operative technique guide states: "warning: please ensure precise alignment of the affected hip joint when using these templates.Template magnification is 15 %.All dimensions (nail angle and implant sizing) resulting from using these templates must be verified intra-operatively to ensure proper implant selection¿ the ifu also states: "warning: ¿ implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation." "warning: ¿ 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." if the device is returned or if any additional information is provided, the investigation will be reassessed.Device was discarded.
 
Event Description
Before the operation, confirmed the implant size while looking at the x ray image with surgeon and sales rep.They chose long gamma nail, but it was mistaken right/left; should have selected a right, but chose left.Since it passed to the nurse and there was no opening check, it was confirmed that the nail penetrated the front of the bone when the op advanced and came to the side stop of the distal as it is.Because the tight bones are fragile, they decided that it should be long and relief should be changed to short to complete the procedure.
 
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Brand Name
LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X260MM X 125°
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8767218
MDR Text Key150258182
Report Number0009610622-2019-00528
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Catalogue Number35250260S
Device Lot NumberK01B396
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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