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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LAG SCREW CASE 7; IMPLANT
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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LAG SCREW CASE 7; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hip Fracture (2349); Malunion of Bone (4529)
Event Date 07/01/2019
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.
 
Event Description
The manufacturer became aware of a literature published by department of orthopedics and traumatology, taipei veterans general hospital in taiwan.The title of this report is ¿radiographic risk factors for predicting failure of geriatric intertrochanteric fracture treatment with a cephalomedullary nail¿ which is associated with the stryker ¿gamma3¿ system.The article can be found at doi: 10.1097/jcma.0000000000000042.This report includes research done on 136 patients between the period july 2011 and december 2014.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 (15) cases of failure due to varus change of the proximal fragment with screw cut-out.
 
Event Description
The manufacturer became aware of a literature published by department of orthopedics and traumatology, taipei veterans general hospital in taiwan.The title of this report is ¿radiographic risk factors for predicting failure of geriatric intertrochanteric fracture treatment with a cephalomedullary nail¿ which is associated with the stryker ¿gamma3¿ system.The article can be found at doi: 10.1097/jcma.0000000000000042.This report includes research done on 136 patients between the period july 2011 and december 2014.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 (15) cases of failure due to varus change of the proximal fragment with screw cut-out.
 
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged screw cut-out mentioned in the article could not be confirmed, however, the literature clearly indicates that the increased dpg is highly associated with failure of varus change of the proximal fragment, which is closely related to entry point selection and canal preparation.So it can be concluded that the event is user-related.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
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Brand Name
UNKNOWN GAMMA3 LAG SCREW CASE 7
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 Key11087127
MDR Text Key224412450
Report Number0009610622-2020-01076
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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