MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON SM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 09.804.600S

Device Problem Material Integrity Problem (2978)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(4) reports an event as follows: it was reported that the patient underwent a percutaneous vertebroplasty (t12 left) procedure treating t12 compression fracture on (b)(6) 2021.When the trial balloon was inflated up to 4.0 ml (170 psi), the balloon broke, and contrast medium leaked.The contrast medium was removed from the patient¿s body.No further information is available.This report is for a trial balloon.This is report 1 of 2 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, h4, h6: the dhr of product code:09.804.600s, lot : 82211802, was electronically reviewed and no non-conformances, were observed during the manufacturing process.The product was released on:04 feb 2021, qty: (b)(4).The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device also.Visual analysis of the returned sample revealed that vbs w/balloon sm the balloon was punctured, and no other issues were identified.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of vbs w/balloon sm in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for vbs w/balloon sm.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: vbs catheter assembly, vbs balloon.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: VBS W/BALLOON SM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12446971
• MDR Text Key: 270545628
• Report Number: 8030965-2021-07597
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819471849
• UDI-Public: (01)07611819471849
• 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
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.600S
• Device Lot Number: 82211802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 09/20/2021
• Patient Sequence Number: 1
• Treatment: VBS W/BALLOON SM; VBS W/BALLOON SM