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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LAG SCREW; IMPLANT
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STRYKER TRAUMA KIEL UNKNOWN LAG SCREW; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Malposition of Device (2616)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 02/07/2019
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
 
Event Description
The manufacturer became aware of a literature published by donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses incorrect position of femoral neck screw followed by revision.
 
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged incorrect position mentioned in the article could not be confirmed, however, the literature clearly indicates that the incorrect position was corrected, so it can be concluded that the root cause of the event is user related due to incorrect positioning of the lag screw.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
Event Description
The manufacturer became aware of a literature published by donauspital wien, in austria.The title of this report is ¿surgical revision for complications after gamma 3-nailing osteosynthesis of proximal humeral fractures¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at https://doi.Org/10.1007/s00113-019-0607-y.Within that publication which involved 1500 patients, post-operative complications were reported, which allegedly occurred from 2008 to 2013.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses incorrect position of femoral neck screw followed by revision.
 
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Brand Name
UNKNOWN LAG SCREW
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key11152561
MDR Text Key226597105
Report Number0009610622-2021-00221
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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