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 05/02/2023

Event Type  malfunction  

Event Description

Device report from synthese reports an event in japan as follows: it was reported that on (b)(6) 2023, a percutaneous vertebroplasty (th12) for compression fracture was performed.The surgeon proceeded according to the surgical technique and chose the m-sized balloon.The surgeon deployed the trial balloon in the vertebral body with no problem and inflated the trial balloon to the specified value using an inflation system.However, when the surgeon was about to remove the trial balloon to switch to the stent balloon, the side of the vertebral body was checked with an image intensifier, and it was found that the contrast agent was leaking inside the vertebral body.The surgeon deflated the trial balloon and removed it.The surgeon also removed the contrast agent leaked inside the vertebral body and confirmed that there was no contrast agent left in the body.The surgeon stopped using the balloon in question and used another product in the surgery.The procedure was completed successfully within a 30-minute delay.When the trial balloon was checked after removing it, it was found that there was a pin hole on it and the contrast agent leaked from the pin hole.The patient status/outcome was reported to be stable.This report involves one vertebral body set/medium- sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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.Device history lot: part # 09.804.601s synthese lot # 82247702 supplier lot # 82247702 release to warehouse date: 18 may 2022 supplier: confluent medical technologies no ncrs were generated during production.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.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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16946020
• MDR Text Key: 315381099
• Report Number: 8030965-2023-06249
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 82247702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1