MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SET/MEDIUM- STERILE; ARTHROSCOPE

Catalog Number 09.804.601S

Device Problem Material Integrity Problem (2978)

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

Event Date 10/14/2022

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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: reporter is a j&j employee.Device is not distributed in the united states, but is similar to device marketed in the usa.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 on (b)(6) 2022 during a percutaneous vertebroplasty for the compressed fracture procedure, the trial balloons for left and right were inflated up without any trouble, however while attempting to perform additional inflation from 4cc 4.5atm, the right balloon was broken.The left balloon was used for inflation.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) vertebral body set/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.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a device history record (dhr) review was not conducted as manufacturing records related to the provided lot number were not available.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 vertebral body set/medium- sterile had signs of breakage, tearing off and deformation at the distal tip of the balloon, these conditions were most likely created during insertion process.The vertebral body set/medium- sterile and the inflation system have been returned to supplier.The technical analysis conducted on the balloon is not compliant.A leak is observed on the balloon.According to the description of the incident, the dolphin was not replaced to complete the procedure, which means that the dolphin was functional.In this case, the defect reported could be linked to a quality problem of the balloon used (leak) and not to the dolphin.As a consequence, the defect reported could be linked to a quality problem of the balloon used and not to the dolphin.A dimensional inspection for the vertebral body set/medium- sterile was unable to be performed due to post manufacturing damage.The complaint was reviewed with the supplier and 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; it states to stop balloon expansion if any of the following happens: 1.Desired vertebral body height or angle is reached.2.Pressure reaches 30 atm.(440 psi) 3.Vbs volume reaches maximum.The surgical technique guide also contains the following warnings: do not fill the balloons over their maximum volume or pressure.If this is done, they may leak.Vbb maximum volumes differ from vbs maximum volumes.The maximum expanded volumes for vbs are 0.5 ml more than for vbb.The failures observed on the returned device is consistent with failure due to over expansion or pressurization.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 of the vertebral body set/medium- sterile 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.

• Brand Name: VERTEBRAL BODY SET/MEDIUM- STERILE
• Type of Device: ARTHROSCOPE
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15743892
• MDR Text Key: 307630960
• Report Number: 8030965-2022-09409
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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: 82248952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1