MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/MEDIUM- STERILE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 03.804.701S

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2023

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: d2b: additional product code: hrx 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, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 this was a percutaneous vertebroplasty (l2) for osteoporotic vertebral fracture on nov.1, 2023.In the surgery, the pressure did not increase during the dilation of the ballon in question, and when the surgeon checked his hand, he observed a leak of contrast medium near the double lumen portion of the balloon.There might have been an open pinhole, and it was all leaking from there.A spare product was used.The surgery was completed successfully within 30 minutes surgical delay.Patient status/ outcome:stable.No further information is available.This report is for one (1) synflate balloon/medium- sterile 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.H10 additional narrative: d9 h3, h4, h6 investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal section of the shaft and the balloon on the synflate balloon/medium- sterile present fracture in the middle of the balloon and deformation.The protection sleeve was not returned.The synflate® vertebral balloon surgical technique guide was reviewed.Following relevant statements were found.Notes: if it becomes difficult to remove the balloon catheter through the working sleeve, twist the catheter while firmly pulling the catheter.Instructions: if removal is still difficult, remove the balloon catheter(s) along with the working sleeve(s), then re-access the vertebral body using the working sleeve with the trocar assembly.Once the re-access is completed, remove the trocar.While no root cause can be determined for the reported issue, the damaged condition of the balloon is most likely due to the process of trying to extract the device, indicating excessive forces were used.A dimensional inspection for the synflate balloon/medium- sterile was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the synflate balloon/medium- sterile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed? yes, reviewed.Device history part # 03.804.701s; synthes lot # 82251842; supplier lot # 82251842; release to warehouse date: 17 nov 2022; supplier: (b)(4).No ncrs were generated during production.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: SYNFLATE BALLOON/MEDIUM- STERILE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18207332
• MDR Text Key: 328969781
• Report Number: 8030965-2023-14778
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034722719
• UDI-Public: (01)10705034722719
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130146
• 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: 11/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 82251842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1