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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1896-5050S
Device Problem Fracture (1260)
Patient Problems Fall (1848); Failure of Implant (1924); Implant Pain (4561)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.
 
Manufacturer Narrative
Please note corrections to b1, h6 (clinical signs code and conclusion code).
 
Event Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.The instructions for use instructs user that: ¿the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.Explain also the need to appear for the postoperative examinations (e.G.X-ray checks) and for the possible explantation of the implant.¿ 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.However, one of the possible causes of the failure is stumbling of the patient over a curb.If device is returned or any further information is provided, the investigation report will be reassessed.
 
Event Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.
 
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Brand Name
LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM
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 Key10996720
MDR Text Key221249087
Report Number0009610622-2020-00917
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540202512
UDI-Public04546540202512
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1896-5050S
Device Catalogue Number18965050S
Device Lot NumberK0623FB
Was Device Available for Evaluation? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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