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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 32250420S
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 09/02/2013
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
It is reported that the patient came in with pain 5 month after implantation. During revision the broken and dislocated nail was removed.
 
Manufacturer Narrative
The evaluation revealed the broken long nail to be the primary product. During investigation no material, design or manufacturing related matters were found. The nail was documented as faultless prior to distribution. The evaluation revealed that the nail broke most likely in a fatigue fracture after a period of approx. 6 months of implantation. The kind of the bone fracture was not provided. This investigation is based on limited medical information and on provided photographs, only. On one image the original coating in the posterior web of the drill hole was removed on the proximal part of the nail. This area was located close to an area with potential deformation found at lateral on the distal part of the nail. It could not be determined whether the material had become scuffed off by usual (micro-) motion between nail and lag screw or if this presented an area of material damage ¿ potentially caused intra-operatively. The appearance of the breakage surfaces on the images suggested the webs had cracked from lateral into medial direction. According to the different topographies it was assumed the incipient crack was located in the posterior web at lateral. On the distal part of the nail significant material seizing and remarkable material displacement ¿ in the bearing points at medial ¿ suggested high axial load and potentially additional torsional load application. A medical review was not possible due to outstanding medical records. General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation. During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product. Usually a breakage is contributed by one or more deficits, e. G. Insufficient bone healing, product damage. Generally the risk of a breakage will increase with the increase of load cycles and load level. Nail breakage in general has been experienced, but does not present an unanticipated event in itself. Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e. G. Increased post-operative activities ¿ a nail breakage can rather be classified as anticipated; specifically if one or more contributing issues concurrence with each other. In this case it could not be determined whether the implant was suitable for treating the bone fracture, there was no information available if the implants had been placed in suitable manner and there was no information available if bone healing had developed in sufficient manner. Further, there was no information regarding potential patient diseases resp. Potential medication. As no post-operative weight bearing instructions were noted it could not be determined if the patient had been compliant resp. If the surgeon¿s instructions were appropriate. From technical point of view a more precise statement was not possible. The file will be closed formally. In case further relevant information or the implant itself becomes available, we reserve the right to update the investigation and change the root cause. According to available information a deficiency of the nail was not be verified.
 
Event Description
It is reported that the patient came in with pain 5 months after implantation. During revision the broken and dislocated nail was removed.
 
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Brand NameLONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM 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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5781679
MDR Text Key49130584
Report Number0009610622-2016-00323
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Catalogue Number32250420S
Device Lot NumberK389681
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/11/2016 Patient Sequence Number: 1
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