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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
Event Date 11/17/2013
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 royal bournemouth hospital in uk. The title of this report is ¿gamma-3 nail mechanical failure. A report of two cases and a comprehensive review of literature¿ published on november 17, 2013, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at https://doi. Org/10. 1007/s12570-013-0233-z. This report includes research done on 2 patients between the period 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 implant failure with breakage of gamma nail at the junction with the lag screw, nonunion of the subtrochanteric fracture, and a new fracture line of the lateral cortex of femoral shaft. The report states: ¿four months later, he found walking impossible due to pain of his left hip which started suddenly with no history of trauma. Check x-rays revealed implant failure with breakage of gamma nail at the junction with the lag screw, nonunion of the subtrochanteric fracture, and a new fracture line of the lateral cortex of femoral shaft. After removal of broken nail, the fracture was fixed with a 95° dcs plate. ¿.
 
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Brand NameUNKNOWN GAMMA3 NAIL
Type of DeviceIMPLANT
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 Key12216459
MDR Text Key263097867
Report Number0009610622-2021-00621
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received07/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/23/2021 Patient Sequence Number: 1
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