MAUDE Adverse Event Report: DEPUY SPINE INC UNK BIOMATERIAL - CEMENT DELIVERY DEVICES; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problems Migration or Expulsion of Device (1395); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023 a percutaneous vertebroplasty and thoracolumbar spine fusion were being performed for a vertebral body fracture.When cement injection was performed, the cement did not come out from the tip of the open cannula, it leaked from the welded part on the side.The procedure was completed successfully with no surgical delay.There was no adverse patient impact.No further information is available.This report is for an unk biomaterial - cement delivery devices.This is report 1 of 1 for (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: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

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: 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 the unknown biomaterial - cement delivery devices was found broken from the tip, it could be the reason of the unable to transfer condition.Therefore, the alleged reported condition can be confirmed.No other issues were found.Since the device was returned with residues of mix cements and damaged, the complaint condition of leakage was not able to be replicated.However, leakage of the cement mention in the event description is most likely due to the breakage condition.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the unk biomaterial - cement delivery device would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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: UNK BIOMATERIAL - CEMENT DELIVERY DEVICES
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17957424
• MDR Text Key: 325943976
• Report Number: 1526439-2023-02081
• Device Sequence Number: 1
• Product Code: NDN
• 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

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1