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

Catalog Number UNK_KIE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Perforation of Vessels (2135); Hip Fracture (2349); Implant Pain (4561)

Event Date 05/09/2014

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of orthopaedics and traumatology, lausanne university hospital, switzerland¿.The article can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.04.016.The reported event of progressive pain and migration of lag screw, which required revision, 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's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedics and traumatology, lausanne university hospital, switzerland¿.The title of this report is ¿medial migration of lag screw after gamma nailing¿, published on may 09, 2014, and can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.04.016.The report is associated with the stryker ¿gamma 3 nailing system¿ and includes an analysis of the clinical data that was collected on 1 patient.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one (1) patient experienced progressive pain, and medial migration of the lag screw through the femoral head and into the pelvis.The lag screw touched a branch of the left internal iliac artery, which required embolization, implant removal, and total hip arthroplasty (tha).The report states, ¿the computed tomography (ct) scan performed showed that the lag screw touched a branch of the left internal iliac artery (figs.7 and 8).This branch was embolized, then the patient was taken to the or for implant removal (which was sent to microbiology for sonication), resection of the head and neck, autologous grafting of the acetabular defect, and replacement by a total hip arthroplasty (tha) [¿]¿.

Manufacturer Narrative

Please note corrections to h6 component code, h6 method code, h6 results code, and h6 conclusion code.This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of progressive pain, and medial migration of the lag screw through the femoral head and into the pelvis.The lag screw touched a branch of the left internal iliac artery, which required embolization, implant removal, and total hip arthroplasty (tha) could be confirmed, from the available radiographs in the literature.Based on the available information and x-ray a formal medical opinion was sought out that a reversed oblique fracture of the left femur is visible.The reduction is acceptable.However, it looks as if the lag screw is positioned a little proximally in the ap-view and anteriorly in the axial vie.The analysis provided in the literature also includes the fact, that the set screw was not placed in one of the groves of the lag screw allowing for the migration.The reason behind the alleged failure is most likely the lag screw and set screw positioning and osteopenic bone of the patient.From the medical opinion the primary root cause can be attributed to as patient related factor and the secondary root cause as surgery related factors that led to the complications.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedics and traumatology, lausanne university hospital, switzerland¿.The title of this report is ¿medial migration of lag screw after gamma nailing¿, published on may 09, 2014, and can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.04.016.The report is associated with the stryker ¿gamma 3 nailing system¿ and includes an analysis of the clinical data that was collected on 1 patient.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one (1) patient experienced progressive pain, and medial migration of the lag screw through the femoral head and into the pelvis.The lag screw touched a branch of the left internal iliac artery, which required embolization, implant removal, and total hip arthroplasty (tha).The report states, ¿the computed tomography (ct) scan performed showed that the lag screw touched a branch of the left internal iliac artery (figs.7 and 8).This branch was embolized, then the patient was taken to the or for implant removal (which was sent to microbiology for sonication), resection of the head and neck, autologous grafting of the acetabular defect, and replacement by a total hip arthroplasty (tha) [¿]¿.

• Brand Name: UNKNOWN GAMMA 3 LAG SCREW
• 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 Key: 15261790
• MDR Text Key: 298255848
• Report Number: 0009610622-2022-00387
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/26/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female