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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 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 Necrosis (1971)
Event Date 08/31/2021
Event Type  Injury  
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of ipsilateral osteonecrosis 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.Device disposition unknown.
 
Event Description
The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery, st.Vincent¿s hospital, the catholic university of korea, republic of korea¿.The title of this report is ¿additional use of anti-rotation u-blade (rc) decreases lag screw sliding and limb length inequality in the treatment of intertrochanteric fractures¿, published on august 31, 2021, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at https://doi.Org/10.1038/s41598-021-96988-z.This report includes an analysis of the clinical data that was collected on 152 patients.The cases in this study range from january 2014 to december 2018.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced ipsilateral osteonecrosis.The report states, ¿¿there was one patient with ipsilateral osteonecrosis and two with distal locking screw breakage postoperatively, neither of whom required any further management".
 
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Brand Name
UNKNOWN GAMMA 3 NAIL
Type of Device
ROD, 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 Key14824528
MDR Text Key294942740
Report Number0009610622-2022-00301
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 06/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2022
Initial Date FDA Received06/26/2022
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 Sequence Number1
Patient Outcome(s) Other;
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