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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 Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18965050S
Device Problems Difficult to Remove (1528); Sticking (1597); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2016
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
 
Event Description
The customer reported that the surgeon was performing a gamma nail procedure and doing free hand distal locking.When the surgeon tried to insert the screw it became stuck and rather than taking the screw out to re-drill, he continued to turn the screw.The thread on the screw head wore away.The reported screw was too difficult to remove and so it was left in situ.The case was completed successfully.
 
Manufacturer Narrative
Evaluation revealed the locking screw, fully threaded to be the primary product.Information regarding concomitant products is not available.A review of the dhr revealed no discrepancy in material or manufacturing.A physical evaluation was impossible as the device was not available for evaluation as it is still implanted.The root cause was already given within product inquiry ¿when the surgeon tried to insert the screw it became stuck and rather than taking the screw out to re-drill, he continued to turn the screw.The thread on the screw head wore away¿ and thus, the case is rather related to deviation from surgical technique.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
 
Event Description
The customer reported that the surgeon was performing a gamma nail procedure and doing free hand distal locking.When the surgeon tried to insert the screw it became stuck and rather than taking the screw out to re-drill, he continued to turn the screw.The thread on the screw head wore away.The reported screw was too difficult to remove and so it was left in situ.The case was completed successfully.
 
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Brand Name
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 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
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5546266
MDR Text Key42075840
Report Number0009610622-2016-00188
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2020
Device Catalogue Number18965050S
Device Lot NumberK05C472
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2016
Initial Date FDA Received04/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2015
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) Other;
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