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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 LONG NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 LONG NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Date 12/30/2017
Event Type  Injury  
Event Description
The manufacturer became aware of a literature published by the orthopaedic institute, the first affiliated hospital of soochow university, china. The title of this report is ¿a comparative study of long third-generation gamma nail and long proximal femoral nail antirotation in the treatment of subtrochanteric femoral fracture ¿, published on december 30, 2017, which is associated with the stryker ¿gamma 3 nailing¿ system. The article can be found at /issn:1940-5901/ijcem0052722. This report includes analysis of the clinical data that was collected on 66 patients, the cases in this study range from february 2006 to october 2015. During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available. It was reported that 2 patients experienced non-union at least 1 of the patients received autogenous iliac bone grafting.
 
Manufacturer Narrative
This record is a consolidation of events summarized as part of literature review, when device and patient information is not available. This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged non-union mentioned in the article could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author. More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
 
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Brand NameUNKNOWN GAMMA 3 LONG NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key13691204
MDR Text Key288358145
Report Number0009610622-2022-00082
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
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
Date Manufacturer Received02/11/2022
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: 03/08/2022 Patient Sequence Number: 1
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