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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 THREADED GUIDE WIRE CASE 2 INSTRUMENT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 THREADED GUIDE WIRE CASE 2 INSTRUMENT Back to Search Results
Catalog Number UNK_KIE
Device Problem Unintended Movement (3026)
Patient Problem Perforation (2001)
Event Date 08/24/2015
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 424 military general hospital, thessaloniki in greece. The title of this report is ¿subtrochanteric femoral fractures treated with the long gamma3® nail: a historical control case study versus long trochanteric gamma nail¿ which is associated with the stryker ¿gamma nailing¿ system. The article can be found at http://dx. Doi. Org/10. 1016/j. Otsr. 2015. 06. 018. This report includes research done on 158 patients between the period 2000 and 2005. 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 (4) cases of perforation of acetabulum (by the threaded guide wire) in the group of the patients treated with the lg3n (long gamma3 nail).
 
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Brand NameUNKNOWN GAMMA3 THREADED GUIDE WIRE CASE 2
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11011686
MDR Text Key221538326
Report Number0009610622-2020-00960
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
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 Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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