MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY STENT-LARGE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.502S

Device Problem Mechanical Problem (1384)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure the surgeon had issues when placing the stent.The stent came loose from the balloon and it could not be opened.The patient is doing well and the procedure finished without any problems.Two more stents were placed.There was no surgical delay.The procedure was completed successfully.This report involves one (1) vertebral body stent-large.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part # 09.804.502s; synthes lot # j002422; supplier lot # 82207441; release to warehouse date: november 30, 2020; supplier: confluent medical technologies, costa rica; no ncr's were generated during production.Visual inspection: vbs large (part# 09.804.502s, lot# j002422, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the balloon got flattened.There is a high possibility of a very small hole in balloon.No other defects were identified with the returned device.The stent was not returned at cq.Functional test: the balloon was observed to not inflate, most likely due to a small hole/damage with unknown time origin.The stent was not returned and hence could not be tested for functionality.Can the complaint be replicated with the returned device(s)? unable to perform as the stent was not returned along with the device.Dimensional inspection: dimensional inspection was not performed as it is not relevant to the reported failure.Document/specification review: the following drawing(s) was reviewed: vbs catheter assembly depuy synthes no design issues or discrepancies were found during this investigation.Complaint confirmed? yes investigation conclusion: the complaint condition is being confirmed for the vbs large (part# 09.804.502s, lot# j002422) as the balloon got flattened.A definitive root cause could not be identified for the reported issue.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 STENT-LARGE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11869803
• MDR Text Key: 252152466
• Report Number: 8030965-2021-04165
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819432628
• UDI-Public: (01)07611819432628
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.502S
• Device Lot Number: J002422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1