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

Catalog Number	03.804.702S
Medical Device Problem Codes	Inflation Problem (1310); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
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.H10 additional narrative: d2: additional procode: hrx d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter phone: (b)(6).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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 03.804.702s synthes lot # 82247720 supplier lot # 82247720 release to warehouse date: 21 jul 2022 supplier: confluent medical technologies 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.
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023 a percutaneous vertebroplasty was being performed.During the procedure, the surgeon dilated the balloon according to the procedure.When attempting to remove the balloon under negative pressure, the balloon was caught in the working sleeve and could not be removed.Applying negative pressure again did not resolve the snagging, so the entire working sleeve was removed.When the balloon was checked outside of the body, the tip appeared to be slightly inflated, causing the snagging.The balloon shaft was cut and removed from the working sleeve.The working sleeve was then reinserted and the surgery continued.The surgery was completed successfully without any surgical delay.No further information is available.This report is for a synflate balloon/large- sterile.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFLATE BALLOON/LARGE- STERILE
• Common Device Name: 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: 18524906
• Report Number: 8030965-2024-00925
• Device Sequence Number: 7950614
• Product Code: NDN
• UDI-Device Identifier: 10705034722726
• UDI-Public: (01)10705034722726
• 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: Physician
• Type of Report: Initial

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: 03.804.702S
• Device Lot Number: 82247720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown