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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30660095S
Device Problem Positioning Problem (3009)
Patient Problem Pneumonia (2011)
Event Date 02/09/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Product remains implanted.
 
Event Description
On (b)(6) 2016, gamma3 primary surgery was performed. 1 week after surgery, the rotation of the femoral head was found slightly. 2 weeks after surgery, the cutout of the u-lag screw was found. Because of pneumonia, the revision surgery is not planned at present. The patient is low activity and using a wheelchair.
 
Manufacturer Narrative
The evaluation revealed the u-blade set, ti gamma3® ø10. 5x95mm and the long nail kit r1. 5, ti, left gamma3® ø10x280mm x 120° to be both subject products. The end cap as well as both locking screws are classified as concomitant products and thus, not subject of this report. No deviations were found during review of the manufacturing and inspection documents (dhr). The items were documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. As the devices are still implanted and thus, not available for evaluation, investigation is limited on x-rays of medium quality provided. Revision surgery due to cut out is a typical complication of proximal femoral nailing. This harm does not primly depend on the implant. It is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primly the respective surgical technique (correct positioning of the lag screw in the center of the femoral head). In the case of a cut out an extensive damage of the hip joint would result which has to be treated with arthroplasty. In many cases a permanent harm would result from such an event (s4). According to literature, the rate of cut out is 1 - 5 % (o5) with any implant which is currently available on the market. Though it is estimated as "high risk" the devices in question are best state of the art and there are no possibilities for further mitigation of the risk from a clinical point of view (see ¿sketch of intended interaction of lag screw / set screw from op-tech¿). From a technical point of view, it was concluded that the femoral neck had rotated over the lag screw, whilst the femoral head was penetrated by the tip of the lag screw, which presents a cut-out after an implantation period of only two weeks. In the case presented, the lag screw was not placed in the center of the femoral head but very inferior, which is suboptimal (see photo [2]). Like already stated in the event description after only one week post-operatively on the x-ray it is clearly visible that the femoral head had rotated slightly over the lag screw (see photo [3]). The x-ray taken two weeks post-operatively clearly shows the cut out (see photo [4]). The intended lateralization of the lag screw did only marginally occur as seen on the x-rays. Most likely the set screw was tight at the lag screw for some reason preventing further lateralization. Due to the too static construct of the implants the femoral head rotated and slipped over the lag screw resulting in cut out. As the nail, set screw and lag screw are not available for evaluation the exact fit of the implants cannot be reproduced on the basis of e. G. Imprints and abrasion. Any substantive patient data were not available either. Thus, a more precise statement regarding the root cause for the cut out is not possible. 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(s). No non-conformity was identified.
 
Event Description
On (b)(6) 2016, gamma3 primary surgery was performed. One week after surgery, the rotation of the femoral head was found slightly. Two weeks after surgery, the cutout of the u-lag screw was found. Because of pneumonia, the revision surgery is not planned at present. The patient is low activity and using a wheelchair.
 
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Brand NameU-BLADE SET, TI GAMMA3® Ø10.5X95MM
Type of DeviceROD, 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 Key5498340
MDR Text Key40245908
Report Number0009610622-2016-00125
Device Sequence Number1
Product Code HSB
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number30660095S
Device Lot NumberK07A867
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2016 Patient Sequence Number: 1
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