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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-4107
Device Problem Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "right tibia t2 orif.After assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed." delay of 4-5 minutes."at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).".
 
Event Description
As reported: "right tibia t2 orif.After assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed." delay of 4-5 minutes."at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).".
 
Manufacturer Narrative
The evaluation revealed the targeting arm tibia t2 alpha tibia and the nail adapter tibia t2 alpha tibia to be the primary products; the nail holding screw was not provided.No deviations were found during review of the manufacturing and inspection documents (dhr).Both products returned were documented as faultless prior to distribution.The risk management file review showed that the complained event was addressed adequately; no threshold exceedances found.The event description includes: ¿after assembling the nail adapter tibia and the targeting arm tibia, the screw was inserted.After that, i tried to remove it, but it could not be removed at the time of the event, the proximal screw had been inserted, so it was removed from the nail and the distal screw was inserted (radiolucent drill).¿ most likely with ¿screw¿ the nail holding screw was meant.The inspection revealed that a sample nail holding screw could be assembled and disassembled easily and within specification, so the reported event was not reproducible.The nail holding screw contains a self-holding clamp that creates a slight resistance.Most likely this resistance caused the event as the user was not familiar with this design feature.If the nail holding screw, used in the surgery, was damaged could not be verified.The event was classified as user related (lack of knowledge).As a secondary issue it was found that the knob to lock the nail adapter to the targeting arm is moveable only with resistance; this phenomenon was already addressed by two non-conformity reports, as microscopical inspection revealed metal particles on the surfaces of moveable bolt and helix sleeve, causing jamming of the locking mechanism; the origin of the metal particles is still unknown, and the ncs are still open.
 
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Brand Name
TARGETING ARM TIBIA T2 ALPHA TIBIA
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 Key10632035
MDR Text Key221277123
Report Number0009610622-2020-00557
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07613327357080
UDI-Public07613327357080
Combination Product (y/n)N
PMA/PMN Number
K193308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2353-4107
Device Catalogue Number23534107
Device Lot NumberKME914842
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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