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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC STABILIZING PLATE OMEGA 3 135°, 4 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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STRYKER GMBH TROCHANTERIC STABILIZING PLATE OMEGA 3 135°, 4 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT Back to Search Results
Model Number 597404S
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/26/2019
Event Type  malfunction  
Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
 
Event Description
As reported: "the omega 3 system was chosen to provide fixation of an intertrochanteric fracture on a male trauma patient of unknown age.The omega 135° guide was used to insert the omega guide pin.Omega reamer and omega tap were used before insertion of lag screw.An omega 3 lag screw (95mm) was implanted over the omega guide pin.The surgeon decided to exchange it for a longer lag screw.The rear part (screw/ driver interface) of the 95mm lag screw was visually deformed after extraction.An omega 3 lag screw (105mm) was then inserted over the guide wire.During insertion, the distal (rear) part of the screw began to deform (at the screw/ driver interface).The deformation was visualized by the surgeon.The surgeon attempted to install the omega 3 stabilization plate onto the lag screw without success.The lag screw screwdriver was not able to remove the damaged lag screw.A conical extractor was used to successfully remove the lag screw.A new omega 3 lag screw (100mm) was then inserted over the guide wire.The omega stabilization plate did not fit the bone to the surgeon's liking and was replaced with an omega short barrel hip plate 135°, 2 hole.X (4.5 x 40mm) screws were inserted through the plate into the femur shaft to secure the plate to the bone." additionally reported: "surgery was prolonged about an hour and a half because of the implant malfunction.".
 
Event Description
As reported: "the omega 3 system was chosen to provide fixation of an intertrochanteric fracture on a male trauma patient of unknown age.The omega 135° guide was used to insert the omega guide pin.Omega reamer and omega tap were used before insertion of lag screw.An omega 3 lag screw (95mm) was implanted over the omega guide pin.The surgeon decided to exchange it for a longer lag screw.The rear part (screw/ driver interface) of the 95mm lag screw was visually deformed after extraction.An omega 3 lag screw (105mm) was then inserted over the guide wire.During insertion, the distal (rear) part of the screw began to deform (at the screw/ driver interface).The deformation was visualized by the surgeon.The surgeon attempted to install the omega 3 stabilization plate onto the lag screw without success.The lag screw screwdriver was not able to remove the damaged lag screw.A conical extractor was used to successfully remove the lag screw.A new omega 3 lag screw (100mm) was then inserted over the guide wire.The omega stabilization plate did not fit the bone to the surgeon's liking and was replaced with an omega short barrel hip plate 135°, 2 hole.X (4.5 x 40mm) screws were inserted through the plate into the femur shaft to secure the plate to the bone." additionally reported: "surgery was prolonged about an hour and a half because of the implant malfunction.".
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
TROCHANTERIC STABILIZING PLATE OMEGA 3 135°, 4 HOLES
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key9614101
MDR Text Key193346393
Report Number0008031020-2020-00115
Device Sequence Number1
Product Code KTT
UDI-Device Identifier07613154687428
UDI-Public07613154687428
Combination Product (y/n)N
PMA/PMN Number
K081278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number597404S
Device Catalogue Number597404S
Device Lot NumberD30505
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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