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

Catalog Number 07.702.040S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery for a right femoral trochanteric fracture with the tfna nail and augmentation.Three milliliters of cement were injected, and the surgeon checked the image for final confirmation.The images showed that trace amounts of the cement were leaking from the hole in the anti-rotation pin that had been inserted in front of the nail.The operation was completed by the surgeon¿s decision.According to the surgeon, the cement was injected into the anti-rotation pin without realizing that it had penetrated during cement injection.It caused the cement leakage.The surgery was completed successfully without any surgical delay.The patient outcome was reported to be stable.No further information is available.This report involves one 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: 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 (dhr): part # 07.702.040s lot # 3a53580 manufacturing site: werk selzach logistik release to warehouse date : 17jan.2023 expiration date: 01.Jan.2026 supplier: osartis gmbh a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18055987
• MDR Text Key: 327171166
• Report Number: 8030965-2023-13749
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07611819453425
• UDI-Public: (01)07611819453425
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.040S
• Device Lot Number: 3A53580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRAUMA NEEDLE KIT Ø 3.3 MM, CANNULA WITH; TRAUMACEM V+ SYRINGE KIT 4*1 ML 2*2 ML; UNK - GUIDE/COMPRESSION/K-WIRES