MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE

Catalog Number 07.702.040S

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that on an unknown date, the patient underwent an unknown surgery with a competitor¿s short nail for a femoral trochanteric fracture.After the surgery, a secondary fracture occurred, and a revision surgery with a cerclage cable, tfna long nail, and cement was performed on (b)(6) 2024.During the revision surgery, after all the fixation procedures were completed, a final check with an image intensifier revealed cement leakage into the soft tissue near the calcar in the joint and above the end cap.The cement above the end cap was removed, but the cement near the calcar was not removed at the surgeon¿s discretion, and the patient was to be monitored.The surgery was completed successfully within 30 minutes delay.Cement injection was started while viewing the frontal image with an image intensifier, and at that time there was no sign of cement leaking into the calcar.From the time of injection of the cement in the 3rd blue syringe, the cement was injected while checking with the axial view, at which point there was no sign of cement leakage.No further information is available.This report is for a traumacem(tm) v+ injectable bone cement ¿ sterile.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

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.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: TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18686246
• MDR Text Key: 335137474
• Report Number: 8030965-2024-02235
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170802
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• 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 HELICAL BLADE PERF L80 TAN; TRAUMA NEEDLE KIT Ø 3.3 MM, CANNULA WITH; TRAUMACEM V+ SYRINGE KIT 4*1 ML 2*2 ML; UNK - CABLE/WIRE; UNK - SCREWS: LAG