MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL; SCREW, FIXATION, BONE

Catalog Number UNK_KIE

Device Problem Migration (4003)

Patient Problems Fall (1848); Perforation (2001)

Event Date 12/08/2020

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the 'mclaren greater lansing hospital, lansing mi, usa'.The title of this report is 'failure of screw/shell interface in the trident ii acetabular system in total hip arthroplasty' published on august 19, 2022, and can be found at https://doi.Org/10.1016/j.Artd.2022.07.010.The report is associated with the stryker 'gamma 3 nailing system' and includes an analysis of the clinical data that was collected on 2 patients.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 1 patient experienced a screw cutout into the acetabulum, which required a revision surgery.The report states, "she previously underwent surgical stabilization of a right intertrochanteric femur fracture on october 17, 2020, with a short intramedullary nail after a ground-level fall.Imaging in the emergency department demonstrated 21-mm screw cutout with penetration into the acetabulum.The decision was made to take patient for hardware removal and conversion to a right tha.She was taken to the operating room where a direct lateral incision was used.Intraoperatively, the compression bolt was grossly loose within the gamma nail with the only thing preventing the screw from disengaging laterally were the threads on the screw itself.Healing around the greater trochanter was observed, and the nail was removed".

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the 'mclaren greater lansing hospital, lansing mi, usa'.The article can be found at https://doi.Org/10.1016/j.Artd.2022.07.010.The reported event 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.

Manufacturer Narrative

Correction- h6 (results code).This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of a screw cutout into the acetabulum, which required a revision surgery could be confirmed, from the available radiographs in the literature.Based on the available x-ray a formal medical opinion was sought that stated; "it is clear the lag screw from the gamma nail migrated medially and penetrated the femur head and ended in the acetabulum.Since we only see one direction it is hard to judge the reduction of the fracture and actual placement of the lagscrew.From the given information it is not clear whether that first procedure was done according to the operative technique, especially with regard to the set screw which was reported to be loose." based on the available information and formal expert opinion the root cause cannot be given since there is too little information given in the article.More detailed information will be required in order to determine the definitive 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 'mclaren greater lansing hospital, lansing mi, usa'.The title of this report is 'failure of screw/shell interface in the trident ii acetabular system in total hip arthroplasty' published on august 19, 2022, and can be found at https://doi.Org/10.1016/j.Artd.2022.07.010.The report is associated with the stryker 'gamma 3 nailing system' and includes an analysis of the clinical data that was collected on 2 patients.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 1 patient experienced a screw cutout into the acetabulum, which required a revision surgery.The report states, "she previously underwent surgical stabilization of a right intertrochanteric femur fracture on (b)(6) 2020, with a short intramedullary nail after a ground-level fall.Imaging in the emergency department demonstrated 21-mm screw cutout with penetration into the acetabulum.The decision was made to take patient for hardware removal and conversion to a right tha.She was taken to the operating room where a direct lateral incision was used.Intraoperatively, the compression bolt was grossly loose within the gamma nail with the only thing preventing the screw from disengaging laterally were the threads on the screw itself.Healing around the greater trochanter was observed, and the nail was removed".

• Brand Name: UNKNOWN GAMMA 3 NAIL
• Type of Device: SCREW, FIXATION, BONE
• 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: 15443392
• MDR Text Key: 300122966
• Report Number: 0009610622-2022-00432
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/14/2022
• 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: 75 YR
• Patient Sex: Female