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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN SHORT GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Malposition of Device (2616)
Patient Problems Failure of Implant (1924); Perforation (2001); Hip Fracture (2349); Implant Pain (4561)
Event Date 12/29/2014
Event Type  Injury  
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged penetration of the postoperative lag screw migration into the pelvis with no trauma mentioned in the article could be confirmed through the x-rays provided in the given article. More information as well as the affected device must be available to determine the exact root cause of the failure. However, based on past complaint history, the most probable root cause of the migration of lag screw is the inadequate locking of the lag screw with the set screw in the nail, which is user related. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a literature published by department of orthopedics, institute of health biosciences, the university of tokushima graduate school, japan. The title of this report is ¿intrapelvic migration of the lag screw in intramedullary nailing¿ published on december, 29th 2014, which is associated with the stryker ¿gamma3 nailing¿ system. The article can be found at http://dx. Doi. Org/10. 1155/2014/519045. This report includes research done on 1 patient. 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 postoperative lag screw migration into the pelvis with no trauma. The patient was subsequently treated with lag screw removal and revision surgery with total hip arthroplasty. The report states: ¿at 6 weeks after the first operation, she returned to the hospital with a 1-week history of progressive pain in her left hip, but no trauma. Radiography revealed redisplacement of the fracture and intrapelvic migration of the lag screw through the femoral head and the medial wall of the acetabulum, which was separated from the nail body. She was referred to our hospital for revision surgery. [¿] we scheduled a 2-stage operation. First, the migrated lag screw was removed without injury to other pelvic structures. [¿] 3 weeks after the removal surgery, cementless total hip arthroplasty with an autologous bone graft for the bony defect in the acetabulum due to lag screw penetration was performed. ¿.
 
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Brand NameUNKNOWN SHORT 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 Key12771557
MDR Text Key284970017
Report Number0009610622-2021-00776
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
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
Date Manufacturer Received10/12/2021
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: 11/08/2021 Patient Sequence Number: 1
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