MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON MED; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 09.804.601S

Device Problem Material Integrity Problem (2978)

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

Event Date 10/30/2023

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.G4: 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.

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that during a vertebral body stenting (t12) for thoracic compression fracture procedure performed on october 30, 2023, when the balloon in question was being inflated, the pressure dropped all at once.So the surgeon removed it and checked the balloon.The damage to the balloon tip was observed.Before reaching maximum expansion capacity, the balloon was damaged.The surgery was completed successfully without any surgical delay.Patient outcome is reported as stable.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, h3, h6: a product investigation was completed: visual inspection of the returned sample revealed that the vbs w/balloon med was observed with signs of tearing off at the balloon, also the distal tip of the balloon is heavily deformed, these conditions were most likely created during insertion process.The stent component was not returned.A dimensional inspection for the vbs w/balloon med was unable to be performed due to post manufacturing damage.It was confirmed that all parts pass a 100% leak test and all lots have a sample burst test performed as part of lot acceptance.As part of the investigation, the supplier also performed a burst test on 2 new production devices and both burst above the required 30 atmospheres.A visual examination of the burst test samples confirmed the condition of the balloons were consistent with the complaint devices.The vertebral body stent surgical technique guide was reviewed.The failures observed on the returned devices are consistent with failure due to over expansion or pressurization.The event description notes that the balloons reached the maximum guaranteed dilatation capacity and would not expand further and the pressure at rupture was 20 atm.This indicates that pressure was still being applied when the devices had already reached the maximum volume.Per the surgical technique guide, expansion should be discontinued as the maximum volume had been reached.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.The cause of the observed condition is likely due to continuing to pressurize the balloon after the maximum volume had been reached.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.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.H11: corrected data: d4: lot number, g1: physical manufacturer.

• Brand Name: VBS W/BALLOON MED
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18166084
• MDR Text Key: 328512740
• Report Number: 8030965-2023-14557
• Device Sequence Number: 1
• Product Code: NDN
• 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

• 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: 82271069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1