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

Catalog Number 07.702.040S

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 10/23/2023

Event Type  malfunction  

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 expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j employee.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.

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.In the surgery, in an attempt to construct augmentation, when the cement in question was mixed and transferred to a syringe, the cement leaked from between the mixer and transfer lid.This reduced the volume of the cement, so that, when it would normally be able to fill four blue syringes, this time it was only able to fill two and a half blue syringes.The surgeon extruded the amount of the cement that was filled in the side opening cannula with a plunger and used that cement.The surgery was completed successfully without any surgical delay.The surgeon opined that transfer lid was not tightened properly.However, immediately after the surgery, when the mixer and transfer lid were checked, they were cemented together and could not be confirmed.Required amount of cement injected and the surgery was completed.Patient status/ outcome: stable.No further information is available.This report is for one (1) traumacem v+ bone cement injectable.This is report 1 of 1 for complaint (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.The product was not returned to depuy synthes, however photos were provided for review.Visual analysis of the photo revealed that traumacem v+ bone cement injectable.Functionality issues cannot be assessed though a photo investigation.The cement retain sample test was unable to be requested as there was no lot # provided.The overall complaint was unconfirmed as the observed condition of the traumacem v+ bone cement injectable would not contribute 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 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 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 V+ BONE CEMENT INJECTABLE
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18091432
• MDR Text Key: 327603920
• Report Number: 8030965-2023-14070
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.040S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• 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