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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 2353-3907
Medical Device Problem Codes Difficult to Insert (1316); Failure to Align (2522)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event or Problem Description
The end user reported they had a colinear clamp on laterally and when the targeting wing was attached it did hit that clamp.They also reported that with antegrade nails, some roc have mis-matched the patient and made insertion difficult.No adverse consequences were reported to the patient and no clinically significant delay was reported.
 
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Brand Name
DISTAL TARGETING DEVICE FEMUR RETROGRADE
Common Device Name
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 Key12470746
Report Number0009610622-2021-00688
Device Sequence Number14401462
Product Code HSB
UDI-Device Identifier07613327411843
UDI-Public07613327411843
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K203819
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/14/2021
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
Operator of Device Health Professional
Device Model Number2353-3907
Device Catalogue Number23533907
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/16/2021
Initial Report FDA Received Date09/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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