MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON MED; ARTHROSCOPE

Catalog Number 09.804.601S

Device Problems Inflation Problem (1310); Material Integrity Problem (2978)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, this was a percutaneous vertebroplasty (l4) performed.A trial balloon was inflated according to the surgical technique and deflated.The trial balloon was replaced with the stent balloon, negative pressure was applied with an inflation system, and it was confirmed that the 3-way-valve was at 0 ml.After checking both the 3-way-valve and the stent balloon, inflation of the stent balloon was started.The trial balloon expanded without problems and formed a large cavity inside the vertebral body, and the state was proper.However, when the stent balloon was attempted to be inflated, the stent balloon did not inflate at all, the stent did not expand, and the pressure hovered below 10 atm.The stent did not spread, so the surgeon determined that there was an abnormality and removed the stent balloon.Only the stent was remained in the vertebral body.When the stent balloon was inflated outside of the patient¿s body, the stent balloon was found to be torn.Therefore, a new balloon was opened, inserted into the stent remained in the vertebral body, and the surgeon tried to inflate the stent again.The stent was not inflated at the tip, only posteriorly.Finally, cement was injected in that condition.Procedure was completed successfully with thirty(30) minutes of surgical delay.No further information is available.This report is for one (1) vbs w/balloon med.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: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j employee.G4 (510k): device is not distributed in the united states, but is similar to device marketed in the usa.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.

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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product code: 09.804.601s.Lot number: 82265423.Release to warehouse date: 24.Oct.2022.Expiration date: 01.Oct.2025.Manufacturing site: werk selzach.Supplier: (b)(4).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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.G1: manufacturing site name & address corrected h5: device is labeled for single use.

• Brand Name: VBS W/BALLOON MED
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17565065
• MDR Text Key: 321463966
• Report Number: 8030965-2023-10382
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07611819471856
• UDI-Public: (01)07611819471856
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.601S
• Device Lot Number: 82265423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - BIOMATERIAL - CEMENT