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

Catalog Number 09.804.502S

Device Problem Material Integrity Problem (2978)

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

Event Date 12/07/2020

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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during an intervention with our vertebral body stent (vbs) it was difficult to open the stent and the stent detached from the balloon.A new vbs needed to be used to finish the intervention.Two (2) vbs stents were inserted into the vertebral body, but neither were able to be inflated.The stents were attempted to be removed, but only the balloons were removed and the unopened stents remained in place.Another balloon was inserted successfully to inflate both stents.After inspection of the first balloons, it was discovered that the balloons were punctured.There was a surgical delay.This report is for one (1) vertebral body stent-large.This is report 2 of 2 for (b)(4).

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.E1: reporters state: (b)(6).Investigation summary: background: during an intervention with our vbs vertebral body stent the neuroradiologist faced difficulties to open the stent, the stent detached from the balloon.A new vbs needed to used to finish the intervention.H6: investigation flow: damage.Device failure/ defect was identified and the complaint was confirmed.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: h3, h6: the device has been 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: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: manufacturing location: supplier - confluent / inspected and released by: monument release date: june 26, 2020 expiration date: may 01, 2023 part: 09.804.502s, vertrebal body stent-large lot: h890231 (sterile) purchased finished goods traveler met all inspection acceptance criteria.Certificate of conformance supplied by confluent was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging was reviewed per inspection sheet requirements and determined to be conforming.This lot met all visual, sterility, and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Visual inspection: vbs large 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.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.Investigation conclusion: vbs large is being confirmed as the balloon got flattened.A definitive root cause could not be identified for the reported problem.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: 11108839
• MDR Text Key: 224812446
• Report Number: 8030965-2021-00008
• Device Sequence Number: 1
• Product Code: NDN
• 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,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 09.804.502S
• Device Lot Number: H890231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 02/26/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR