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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0095S
Device Problems Material Deformation (2976); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
 
Event Description
On (b)(6) 2021, gamma 3 surgery was performed on the right proximal femur.On (b)(6) 2021, although the details of the breakage are unknown, the u-blade lag screw that was fixed to the gamma 3 nail was found to have failed and moved upward to the head of the bone.The u-lag portion of this lag screw was deformed so that it opened forward.The surgeon plans to collect the defective device when performing the girdle stone later.
 
Manufacturer Narrative
The reported event was confirmed on provided x-rays.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential implant cut-out had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation resp.Support in order to relieve the nail during the implantation period.The labelling points refers in detail to the procedure steps for u-blade lag screw treatment.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a gamma3 u-blade set had protruded through the femur head after an implantation period of allegedly less than 7 weeks.The product was not available for investigation.Received medical documents (including x-rays) revealed the product-id.A medical statement was possible because a second view (in m-l-direction) was not available.Cut out is a typical complication of proximal femoral nailing.This harm does not primarily depend on the implant.It is mostly caused by the kind of fracture, patient's general condition and primarily the respective surgical technique.In this case the root cause was regarded as patient related.In case the item or further substantive information becomes available we reserve the right to reopen the investigation with new root cause assessment.
 
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Brand Name
U-BLADE SET, TI GAMMA3® Ø10.5X95MM
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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12579446
MDR Text Key274828029
Report Number0009610622-2021-00729
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540595997
UDI-Public04546540595997
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3066-0095S
Device Catalogue Number30660095S
Device Lot NumberK086163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2021
Initial Date FDA Received10/05/2021
Supplement Dates Manufacturer Received11/25/2021
Supplement Dates FDA Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceAsian
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