MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE VERTEBRAL BALLOON MED; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	03.804.701S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an unknown surgery performed on (b)(6) 2025.In the surgery, it was confirmed that two balloons were broken.The sales representative was not present during the surgery, so details such as the installation procedures of the balloon and inflation system and conditions were unknown.The surgery was completed successfully without any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H11 additional narrative: corrected: e4.H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the synflate vertebral balloon med had signs of tearing off and breakage in the proximal section of the device.A dimensional inspection and a functional test for the synflate vertebral balloon med were unable to be performed due to post manufacturing damage.Since the device was returned deflated and damaged, the complaint condition of not being able to inflate/deflate was not able to be replicated.However, this is most likely due to the breakage condition of the balloon.Previous complaints were reviewed for 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 synflate vertebral balloon surgical technique was reviewed; states to stop balloon expansion if any of the following happens: the desired outcome is reached the pressure reaches 30 atm (440 psi) the maximum balloon volume is achieved ¿ 4.0 ml for the small balloon ¿ 5.0 ml for the medium balloon ¿ 6.0 ml for the large balloonany part of the inflated balloon length touches the cortical bone.The surgical technique guide also contains the following precautions: - the balloons may leak if they are filled beyond their maximum volume or pressure.- the performance of the balloons catheter may be adversely affected if it comes into contact with bone splinters, bone cement and/or surgical instruments.The surgical technique guide also recommends the following: - to proceed with inflation slowly, stopping every few seconds to allow the bone to adjust to the pressure/volume changes.- for bilateral procedures, inflate each balloon alternately in increments the failures observed on the returned devices are 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 j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the synflate vertebral balloon med 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.Device history review (dhr): part # 03.804.701s.Lot # 82329888.Manufacturing site: werk selzach logistik.Release to warehouse date: 21.Feb.2025.Supplier: (b)(4).Expiration date: 01.March.2030.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFLATE VERTEBRAL BALLOON MED
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH LOGISTIK; 1101 synthes avenue; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22525710
• Report Number: 8030965-2025-07217
• Device Sequence Number: 8550894
• Product Code: NDN
• UDI-Device Identifier: 10705034722719
• UDI-Public: (01)10705034722719(17)300301(10)82329888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 82329888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown