MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: FNS LOCKING; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Migration (4003)

Patient Problems Arthritis (1723); Necrosis (1971); Pain (1994)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unk - screws: fns locking/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: peterson df, schabel k (2023), cold welding of the synthes femoral neck system encountered at conversion to arthroplasty: a case report, jbjs case connect 2023;13:e22.00530, (usa).This study reports a case of a 77-year-old man with parkinson disease and avascular necrosis after femoral neck fracture initially managed with the unknown synthes femoral neck system.The patient was initially presented for management of his left femoral neck fracture after mechanical ground level fall.Review of injury films revealed garden 2 left femoral neck fracture, as well as some early stage radiographic degenerative changes, subsequently treated with unknown synthes femoral neck system.Approximately 1.5 years postoperatively, the patient presented with evidence of post-traumatic avascular necrosis of the femoral head.On interval follow-up films 1 and 1.5 years later, the femoral neck fracture was noted to be appropriately healed; however, there was progressive collapse of the femoral head and subsequent worsening of his underlying arthritis.He was severely debilitated because of pain, with difficulty in weight-bearing despite walker use, and was indicated for conversion to total hip arthroplasty.Intraoperatively, during the planned arthroplasty procedure, the surgeons proceeded first with attempts to remove the transverse screw; however, this was not able to loosen.In attempts at loosening, the screw head recess stripped, whereas the screw remained intact and bonded to the plate.A carbide burr was ultimately required to remove the screw head to allow for removal of the cephalomedullary derotational screw and plate.The residual piece of the transverse screw was then removed using a shukla broken screw device.The remainder of the arthroplasty procedure was performed uneventfully.Consideration was given to cementing the femoral stem; however, this was deemed to be infeasible, given the large defect in the lateral femur remaining after removal of the unknown synthes femoral neck system device.The total surgical time was 95 minutes under spinal anesthesia, with an estimated blood loss of 700 ml.His immediate postoperative course was complicated by urinary tract infection and left gluteal hematoma required readmission and packed red blood cell transfusion.Despite these complications, he recovered well from his arthroplasty procedure.At the 2.5-month postoperative follow-up visit after conversion to total hip arthroplasty (2 years status post his initial fracture stabilization with the unknown synthes femoral neck system device), he was ambulating without assistive devices at home and the office, using a rolling walker for support in the community only.1 year after conversion to total hip arthroplasty, approximately 2.5 years from his initial surgery, the patient has unfortunately had multiple hospital admissions for sequela related to progression of his parkinson disease.He has, however, had no further complications related to his hip surgery.This report is for the unknown synthes femoral neck system.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - screws: fns locking.This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - SCREWS: FNS LOCKING
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17442725
• MDR Text Key: 320229491
• Report Number: 8030965-2023-09660
• Device Sequence Number: 1
• Product Code: KTT
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male