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

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	05/12/2025
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.
Event or Problem Description
It was reported that on (b)(6) 2025 the patient had a orif for a hip fracture with a tfna construct, during the tfna case the operating surgeon elected to utilize traumacem v+ for this particular patient.During normal mixing procedures for the cement, the delivery/mixing container did not dispense cement once the proper mixing instructions were followed.If the lid was opened, the cement was sufficiently mixed and displayed the right consistency when handled.Despite the correct consistency, the cement was unable to be injected into the proper syringes for implantation through the stop-cock device, and thus a 2nd cement package and syringe kit were opened to successfully complete the procedure.There was no surgical delay.The procedure was successfully completed.There was no generation of fragments.
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.H6: 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 review : product code: 07.702.040s.Lot number : 4f53721.Release to warehouse date : 04.Jun.2024.Expiration date : 31.May.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(TM) V+ INJECTABLE CEMENT -S
• 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: 22140046
• Report Number: 8030965-2025-05587
• Device Sequence Number: 12815908
• Product Code: LOD
• UDI-Device Identifier: 10886982262257
• UDI-Public: (01)10886982262257(17)270531(10)4F53721
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 4F53721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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
• Patient Sex: Unknown