MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problems Pain (1994); Physical Asymmetry (4573)

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.Additional narrative: 510k: this report is for an unknown nail head elem: tfna helical blade/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of the following journal article: reimond m., gross t., (2022) femoral neck blade cut-in after internal fixation of a trochanteric femoral fracture with a tfna©, der unfallchirurg case discussion trauma surgeon volume xxxx, pages 1-10 (switzerland).This study presents a case report of a patient following fixation of a trochanteric femoral fracture with a tfna© and despite correct fracture reduction and fixation suffered a complete cut-in, i.E., a medialization of the entire femoral neck blade through the nail into the hip joint.A 96-year-old mr.A suffered a fall at home onto the right side of his body, causing pain in his right hip.No history of osteoporosis known in status post total hip prosthesis on the left side several years ago.Clinically, the right leg was found to be shortened and externally rotated with unremarkable sensitivity and blood circulation in the right leg.The x-ray (rx) of the pelvis and the right hip showed a pertrochanteric fracture of the femur (ao type a1.2).The radiologically documented osteoarthritis in the hip (in the case of status post total hip prosthesis on the opposite side several years ago) had not limited the patient.The osteosynthetic treatment was performed using the proximal femur nail, the tfna© (made by depuy/synthes, zuchwil, switzerland).The postoperative x-ray examination showed an adequate bone and implant position, with typical lateralization of the spiral blade as a result of fracture compression in comparison with the image intensifier images.Transfer on the 8th day after the surgery into rehabilitation and after progressing without any complications, the patient was discharged to go home on the 34th day after the surgery.As a result of increasing hip pain on the right side, his family doctor sent him to the emergency room on the 41st day after the surgery.The x-ray examination showed a "cut-in", i.E., a "migration" of the blade of the femoral neck into the hip joint, so that the blade no longer protruded laterally over the nail and the fracture slightly gaped or was in a varus position.The additional computer tomography of the pelvis showed no evidence of loosening of the blade or relevant acetabular damage (fig.4) when the hip blade penetrated the acetabular fossa.After considering the advantages and disadvantages of each solution, we decided only to change the blade in the over 90-year-old, fully anticoagulated patient and not to perform re-osteosynthesis or a prosthetic treatment with the aim of minimizing the rehabilitation.This was also based on the assumption that, according to the x-ray or ct, there would no longer be any significant shortening, because the fracture zone sintering was already complete as a result of the "impact" of the femoral head-femoral neck fragment laterally or on the femoral nail.This assumption, however, turned out to be incorrect: even shortly after the surgery, further sintering was evident under full load bearing, combined with another cut-in by the blade into the joint, one week after the blade change, a complete removal of the metal was performed with endoprosthetic treatment.After a short stay in intensive care after the surgery, as a result of acute renal insufficiency and because of the symptoms with which the patient presented was delirium, the further progress was basically without complications.At the outpatient follow-up almost 3 months after the last surgery, mr.A., who was back at home with support and was living independently, walked almost without a limp using a walking frame, with only the occasional use of painkillers prn.Active hip mobility was found with internal/external rotation of 10/0/30° (opposite side 20/0/20°) and hip flexion of 110°.While lying down, he was able to lift both legs off the examination table, the right leg was somewhat weaker, with good abduction and adduction movements, although the holding force of the affected leg was reduced.This report is for unknown synthes tfna.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 15006289
• MDR Text Key: 295857268
• Report Number: 8030965-2022-04813
• 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: Foreign,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: 07/13/2022
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Sex: Male