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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL CASE 2 IMPLANT

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL CASE 2 IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ambulation Difficulties (2544)
Event Date 02/22/2017
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 department of orthopedic surgery, assaf harofeh medical center in israel. The title of this report is ¿proximal femoral shortening after cephalomedullary nail insertion for intertrochanteric fractures¿ published on february 22, 2017, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at doi: 10. 1097/bot. 0000000000000835. This report includes research done on 48 patients between the period 2011 and 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 (10) cases failed to retain any prior walking ability and became nonambulatory. The report states of these, 2 patients had fixation failure. Greater pfs (proximal femoral shortening) was found to be associated with fixation failure and inability to retain ambulatory capacity.
 
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Brand NameUNKNOWN GAMMA3 NAIL CASE 2
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 Key12175000
MDR Text Key261779131
Report Number0009610622-2021-00603
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
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 Received06/22/2021
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: 07/15/2021 Patient Sequence Number: 1
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