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	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that during the process of packaging the cement in the syringes, it was evident that it did not flow through the plunger.Initially, the possibility that the cement had been set was considered; however, after a review carried out jointly with the specialist, it was confirmed that the material did not show any signs of setting.It was identified that the fault is in the mechanism of the lever, which does not operate correctly and remains in the lower position, preventing the cement from being driven and, therefore, that the syringes are not filled properly.They are shipped in red bag.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary- 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 history lot- lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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.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: h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the lever was in the upper position.No signs of broken components or any structural damage that could lead to the customer allegation were observed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed.The lever mechanism was moved to the start position; then, the t-handle was actuated to activate the lever mechanism.All components and mechanisms functioned as expected.According to the surgical technique tfn-advanced proximal femoral nailing system (tfna) rev.Af.The following instructions are mentioned.Fill injection syringes once the cement has been prepared remove the small, transparent plug of the mixer lid.Connect the stopcock (the side without the funnel) to the mixer.Ensure a tight fit between the mixer and the stop-cock.Precaution: ensure a good fit between the syringe and the stop-cock/used access solution, but make sure to be on axis and avoid using excessive force when coupling them.They are both made of plastic and could otherwise break.First remove the air from the system.With the valve open, gently turn the handle of the cement mixer clockwise.The mixer piston will advance in the translucent cartridge and a steady flow of cement will move into the stopcock.As soon as the cement is visible in the stop-cock, close the valve.Note: do not push to transfer cement.Attach a 2 ml (white) syringe to the one way stop-cock (funnel side).Open the one way stop-cock (the ¿off¿ sign facing away from the syringe).Gently turn the handle of the cement mixer clockwise to advance the piston.As soon as the syringe is filled, close the stop-cock again, by turning the ¿off¿ sign towards the mixer.Disconnect the full syringe and attach the next syringe to be filled.Avoid spillage of cement into the funnel during the transfer process and remove excess cement to avoid accidental pollution of the protection sleeve or screw.Continue to fill all the 1 ml (blue) and 2 ml (white) syringes in the same manner.Always fill all syringes.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 depuy synthes 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 lot: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22437729
• Report Number: 8030965-2025-06839
• Device Sequence Number: 19623932
• Product Code: LOD
• UDI-Device Identifier: 10886982262257
• UDI-Public: (01)10886982262257
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 4653751
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 03/17/2026; 04/15/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/08/2025; 03/20/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TRAUMA NEEDLE KIT Ø 3.3 MM, CANNULA WITH.; TRAUMACEM V+ SYRINGE KIT 4*1 ML 2*2 ML.
• Patient Sex: Female