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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 11X380MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34251380S
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Non-union Bone Fracture (2369); Implant Pain (4561)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported, during treatment a long gamma3 nail was fractured.The patient had a gamma3 nail in place a few months ago and recently it appeared during the inspection that it had broken.Doctors performed the re-surgery on may 19.
 
Manufacturer Narrative
Correction: refer to d9 / h3 device availability.The reported event could be confirmed with the help of x-rays received and also matches the reported failure mode.A device inspection was not possible since the affected device was not returned.Based on the provided medical records, the medical opinion was sought from an experienced independent medical expert which revealed the following: ¿looking at the follow-up x-rays, it seems the x-ray on (b)(6) 2020 is showing delayed union.Looking in the second direction the repositioning of the fracture might have been off from the start, which does not help in getting the needed stability for bone healing.The x-ray is suggestive of a lack of compression, instability and continuous movement at the fracture site, which will prevent the bone from healing.Compression is also a key factor for the healing of these fractures.The x-rays from on (b)(6) 2020 show a non-union, since the difference with the x-rays from on (b)(6) 2020 is negligible.Looking further at the description of the event, it seems that the fracture did not heal at all after surgery.The gamma-nail is not intended to weight bear for such a long time.If the fracture did not heal, the non-union can be cause of the breakage of the nail, since the nail is not intended to bear that weight/ or those forces at that time after surgery anymore.¿ 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 predominantly user related (inadequate reposition) and is also supported by the medical expert¿s opinion.If the product is returned or any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.
 
Event Description
As reported, during treatment a long gamma3 nail was fractured.The patient had a gamma3 nail in place a few months ago and recently it appeared during the inspection that it had broken.Doctors performed the re-surgery on (b)(6).Additional information received: 05.20: patient made telephone to clinic (due to a pandemic).The patient reports that for more than 1.5 months he has had pain that appeared suddenly after climbing the stairs.Patient denies falling, doctor asked the patient whether he also fell this time but the patient denied.A week later, he was called for control and accepted for surgical treatment.Replacement of anastomosis.
 
Event Description
As reported, during treatment a long gamma3 nail was fractured.The patient had a gamma3 nail in place a few months ago and recently it appeared during the inspection that it had broken.Doctors performed the re-surgery on (b)(6).Additional information received: (b)(6) 2020: patient made telephone to clinic (due to a pandemic) - the patient reports that for more than 1.5 months he has had pain that appeared suddenly after climbing the stairs.Patient denies falling, doctor asked the patient whether he also fell this time but the patient denied.A week later, he was called for control and accepted for surgical treatment.Replacement of anastomosis.
 
Manufacturer Narrative
Correction: refer to d9/h3 device availability the reported event could be confirmed, as the returned device matches the reported failure mode.The device was visually inspected, and the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the posterior web suggests that the nail breakage had its origin in this area.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest on the posterior web.Based on the provided medical records, the medical opinion was sought from an experienced independent medical expert which revealed the following; ¿looking at the follow-up x-rays, it seems the x-ray in (b)(6) 2020 is showing delayed union.Looking in the second direction the repositioning of the fracture might have been off from the start, which does not help in getting the needed stability for bone healing.The x-ray is suggestive of a lack of compression, instability and continuous movement at the fracture site, which will prevent the bone from healing.Compression is also a key factor for the healing of these fractures.The x-rays from (b)(6) 2020 show a non-union, since the difference with the x-rays from 01.2020 is negligible.Looking further at the description of the event, it seems that the fracture did not heal at all after surgery.The gamma-nail is not intended to weight bear for such a long time.If the fracture did not heal, the non-union can be cause of the breakage of the nail, since the nail is not intended to bear that weight/ or those forces at that time after surgery anymore.¿ 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.The raw material quality certificate of the heat number was reviewed.It corresponds to the material defined on the drawing and to the internal material specification.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause of the failure is predominantly user related (inadequate reposition) and is also supported by the medical expert¿s opinion ¿looking in the second direction the repositioning of the fracture might have been off from the start, which does not help in getting the needed stability for bone healing.The x-ray is suggestive of a lack of compression, instability and continuous movement at the fracture site, which will prevent the bone from healing.Compression is also a key factor for the healing of these fractures.Looking further at the description of the event, it seems that the fracture did not heal at all after surgery.If the fracture did not heal, the non-union can be cause of the breakage of the nail, since the nail is not intended to bear that weight/ or those forces at that time after surgery anymore.¿ if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM 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
GM  D-24232
MDR Report Key10155610
MDR Text Key195249735
Report Number0009610622-2020-00292
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,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/30/2023
Device Catalogue Number34251380S
Device Lot NumberK070732
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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