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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3066-0095S
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Perforation (2001); Hip Fracture (2349)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
As reported: "after tha surgery (right side), cutout of a lag screw occurred at the femoral head.After that, the lag screw invaded the pelvis.The initial surgery performed on (b)(6) 2021, the event was confirmed on (b)(6) 2021.The re-operation was performed on (b)(6) 2021.Additional information received on 17-feb-202: "at the time of the initial operation, the operation was completed without inserting the u blade of the u lag screw and the end cap for the lag screw.In addition, it has been confirmed that the lag screw did not turn when the set screw was not loosened in the removal process.So, the surgeon recognized that the set screw was fixed to some extent.".
 
Manufacturer Narrative
Corrections: please refer to section h6 (device code and clinical signs code).The alleged event could be confirmed based on the damage patters on the surfaces of the unbroken returned products.Review of device history, labelling, 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(s).No indications of material, manufacturing or design related problems were found during the document review.Functional inspection assembling of nail, lag screw and set screw in appropriate manner confirmed function was fully given.Having unscrewed the set screw for less than ¼ of a turn the lag screw could safely be locked in every position not leading to exceeded slide or rotation of the lag screw.The event could be reproduced by blocking the lag screw (with the set screw) initially in more medial position ¿ at the level of the edge with the clear imprint.Releasing the lag screw (unscrew >1/4 < ½ turn) ensured free sliding of the lag screw.The lag screw could be pushed far towards medial until the (still) protruding tip of the set screw avoided further motion towards medial which had caused additional imprints.From technical point of view and according to found surface pattern the event was initially caused by inappropriate placement of the set screw resulting in uncontrolled lag screw motion towards medial.The treating surgeon¿s opinion, event occurred due to the set screw, was confirmed.From medical point of view and with available x-rays the event was caused by the treatment (sub-optimal reduction and eccentric lag screw placement) contributed by patient¿s condition (osteopenic bone).The event was caused by inappropriate placement of the set screw ¿ unscrewing > ¼ of a turn ¿ which was regarded as user related.A product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
 
Event Description
As reported: "after tha surgery (right side), cutout of a lag screw occurred at the femoral head.After that, the lag screw invaded the pelvis.The initial surgery performed on (b)(6) 2021, the event was confirmed on (b)(6) 2021.The re-operation was performed on (b)(6) 2021.Additional information received on 17-feb-202: "at the time of the initial operation, the operation was completed without inserting the u blade of the u lag screw and the end cap for the lag screw.In addition, it has been confirmed that the lag screw did not turn when the set screw was not loosened in the removal process.So, the surgeon recognized that the set screw was fixed to some extent.".
 
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Brand Name
U-BLADE SET, TI GAMMA3 10.5X95MM
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 Key11417551
MDR Text Key239567312
Report Number0009610622-2021-00326
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540595997
UDI-Public04546540595997
Combination Product (y/n)N
PMA/PMN Number
K043431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number3066-0095S
Device Catalogue Number30660095S
Device Lot NumberK078223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Date Manufacturer Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight46
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