MAUDE Adverse Event Report: SYNTHES GMBH TRAUMACEM V+ BONE CEMENT INJECTABLE

Catalog Number	07.702.040S
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent osteosynthesis surgery for trochanteric femoral fracture with the cement.The surgeon placed the ampoule into the cartridge and mixed it as instructed, but when the surgeon tried to fill the cement into the syringe, no cement came out.As a result, the surgeon was unable to insert the cement, although it was mixed sufficiently.The surgery was completed successfully with no delay.
Additional 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.H11 additional narrative: added: d9.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Additional 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.H11 additional narrative: added: d10, corrected: g1.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned traumacem v+ bone cement injectable found hardened cement inside of the mixer.No other issues were identified.A complete functional test was unable to performed due to condition of the received device.Therefore, the complaint condition was unable to be replicated.However, retain test was performed by the vendor, osartis.The result of the testing revealed no deviations of product code 07.702.040s, lot # 4l53760; hence the a faulty product was excluded.Properly handling and attention to the approved use of the device diminishes the risk of failure.Instructions for use for traumacem v+ cement kit were reviewed and the following relevant statements were found: always use the full amounts of monomer liquid and polymer powder provided in the kit, respectively, when mixing traumacem v+ injectable bone cement.Ensure that the powder and liquid component are thoroughly mixed before starting cement transfer.Application of traumacem v+ injectable bone cement should be monitored using real time imaging procedures capable of delivering high quality images.Use appropriate imaging techniques to confirm correct needle placement, the absence of damage to surrounding structures and appropriate location and quantity of injected material.Note that cement handling and setting times are heavily dependent on temperature.Higher temperatures reduce the setting time and lower temperatures extend it.At cement temperatures lower than 19°c (66°f), a longer waiting time is needed to reach an appropriate viscosity of the cement.Handling time also depends on many other factors, including (without necessarily being limited to) syringe diameter, cannula diameter and length.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the traumacem v+ bone cement injectable would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): product code: 07.702.040s.Lot number: 4l53760.Release to warehouse date: 21.Nov.2024.Expiration date: 01.Nov.2027.Supplier: (b)(4).Manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H11 additional narrative: corrected: g1.H3, h4, h6 the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned traumacem v+ bone cement injectable found hardened cement inside of the mixer.No other issues were identified.A complete functional test was unable to performed due to condition of the received device.Therefore, the complaint condition was unable to be replicated.However, retain test was performed by the vendor, osartis.The result of the testing revealed no deviations of product code 07.702.040s, lot # 4l53760; hence the a faulty product was excluded.Properly handling and attention to the approved use of the device diminishes the risk of failure.Instructions for use for traumacem v+ cement kit se_295424 rev.Ag were reviewed and the following relevant statements were found at page 5, 6 and 8: always use the full amounts of monomer liquid and polymer powder provided in the kit, respectively, when mixing traumacem v+ injectable bone cement.Ensure that the powder and liquid component are thoroughly mixed before starting cement transfer.Application of traumacem v+ injectable bone cement should be monitored using real time imaging procedures capable of delivering high quality images.Use appropriate imaging techniques to confirm correct needle placement, the absence of damage to surrounding structures and appropriate location and quantity of injected material.Note that cement handling and setting times are heavily dependent on temperature.Higher temperatures reduce the setting time and lower temperatures extend it.At cement temperatures lower than 19°c (66°f), a longer waiting time is needed to reach an appropriate viscosity of the cement.Handling time also depends on many other factors, including (without necessarily being limited to) syringe diameter, cannula diameter and length.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the traumacem v+ bone cement injectable would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review.Product code:07.702.040s.Lot number : 4l53760.Release to warehouse date : 21.Nov.2024.Expiration date : 01.Nov.2027.Supplier: (b)(4).Manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRAUMACEM V+ BONE CEMENT INJECTABLE
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2425 ; SZ 2425
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22612556
• Report Number: 8030965-2025-07526
• Device Sequence Number: 18532879
• Product Code: LOD
• UDI-Device Identifier: 10886982262257
• UDI-Public: (01)10886982262257(17)271101(10)4L53760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.702.040S
• Device Lot Number: 4L53760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 08/15/2025; 08/18/2025; 08/21/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/18/2025; 08/19/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAUMACEM V+ BONE CEMENT INJECTABLE
• Patient Sex: Male