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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent the open reduction internal fixation for the trochanteric fracture of the femur with the trochanteric fixation nail - advanced (tfna) long nail.After the surgery, the fixation was stable so that the patient was in rehabilitation, however pain occurred when he stepped on the clutch while driving.It was confirmed that the tfna long nail and the blade junction was fractured at the time of physician visit and bone healing had not been achieved.The patient underwent the revision surgery.The surgeon confirmed with x-rays, that there were no remnants of fractured implant in the body.The surgeon commented that it is assumed that the full load was applied to the implant, because of the loss of the inside calcar femoral.In the revision surgery, the fractured implant was completely removed and the fracture site was reduced, and the tfna was replaced with a lag screw.The surgeon added impaction to the fracture near the sub-trochanter and engaged it, and inserted two screws laterally to the distal bone.Procedure was completed successfully.The fixation is as stable as before, but the surgeon was concerned about the ability of the implant to withstand the load.This report is for one (1) unk - nail head elements: tfna helical blade.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

510k: this report is for an unk - nail head elements: 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.Reporter is a j&j employee.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.

Manufacturer Narrative

510k: this report is for an unk - nail head elements: 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.Reporter is a j&j employee.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 (b)(6) as follows: it was reported that, the patient underwent the open reduction internal fixation for the trochanteric fracture of the femur with the trochanteric fixation nail - advanced (tfna) long nail.After the surgery, the fixation was stable so that the patient was in rehabilitation, however pain occurred when he stepped on the clutch while driving.It was confirmed that the tfna long nail and the blade junction was fractured at the time of physician visit and bone healing had not been achieved.The patient underwent the revision surgery.The surgeon confirmed with x-rays, that there were no remnants of fractured implant in the body.The surgeon commented that it is assumed that the full load was applied to the implant, because of the loss of the inside calcar femoral.In the revision surgery, the fractured implant was completely removed and the fracture site was reduced, and the tfna was replaced with a lag screw.The surgeon added impaction to the fracture near the sub-trochanter and engaged it, and inserted two screws laterally to the distal bone.Procedure was completed successfully.The fixation is as stable as before, but the surgeon was concerned about the ability of the implant to withstand the load.This report is for one (1) unk - nail head elements: tfna helical blade.This is report 2 of 2 for complaint (b)(4).

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.D10: date of concomitant therapy is (b)(6), 2021.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.

• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13445066
• MDR Text Key: 285327424
• Report Number: 8030965-2022-00686
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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
• Treatment: TFNA FEM NAIL Ø10 LE 125° L340 TIMO15.; UNK - END CAPS: TFNA.; UNK - SCREWS: NAIL DISTAL LOCKING.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male