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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL CONDYLE SCREW T2 FEMUR Ø5X75 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1895-5075S
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
The customer reported that "as we have just discussed by telephone, i am sending you an e-mail to inform you of an incident concerning the placement of a retrograde s2 femur nail on monday.Indeed, when the transcondylar screw was placed in compression, it never screwed in despite the 1.8 pin and the drilling on both sides of the condyle." additional information received: "the procedure was completed correctly but without this transcondylar compression screw.No clinical consequences to date.Yes, the procedure was delayed by about 20 minutes.No additional medical intervention, but we used the image intensifier more than usual, which could have had repercussions on the patient and the personnel present.".
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
The customer reported that "as we have just discussed by telephone, i am sending you an e-mail to inform you of an incident concerning the placement of a retrograde s2 femur nail on monday.Indeed, when the transcondylar screw was placed in compression, it never screwed in despite the 1.8 pin and the drilling on both sides of the condyle." additional information received: "the procedure was completed correctly but without this transcondylar compression screw.No clinical consequences to date.Yes, the procedure was delayed by about 20 minutes.No additional medical intervention, but we used the image intensifier more than usual, which could have had repercussions on the patient and the personnel present.".
 
Manufacturer Narrative
The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned device shows signs of usage evident by intense scratches on the shaft of the screw.Appearance of heavy scratches on the screw surface and deformation of the head indicate that the insertion and/or extraction of the screw required great amount of force, possibly caused due to misalignment, consequently interacting with the nail and the washer.Some portion of the threads look flattened with faded anodization which is also indicative of the fact that the screw was not inserted properly and was rather misaligned.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.Based on the above investigation, the root cause of the issue is user related as evident by the signs of misaligned insertion.If more information is provided, the case will be reassessed.
 
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Brand Name
CONDYLE SCREW T2 FEMUR Ø5X75 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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14102939
MDR Text Key289217117
Report Number0009610622-2022-00131
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540202185
UDI-Public04546540202185
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K014220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1895-5075S
Device Catalogue Number18955075S
Device Lot NumberK027A8F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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