MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/MEDIUM- STERILE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 03.804.701S

Device Problem Inflation Problem (1310)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrx.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 during a procedure on (b)(6) 2021, the synflate vertebral balloon could be placed into the sleeve in a deflated state because it was too stiff.No further information provided.This report is for one (1) synflate balloon/medium- sterile.This is report 1 of 1 for complaint (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.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

A 4-level balloon kyphoplasty lwk 1-4 procedure was performed for osteoporotic fracture of 3 vertebral bodies (lwk 1, 2, 4).A 15 minute surgery prolongation occurred, due to frustrating advancement of the defective balloon, as well as exchange of the defective balloon for a new one.After removal of the kyphoplasty balloon from its packaging and appropriate deflation, the balloon could not be inserted into the vertebra via the working cannula of the jamshidi needle as usual.The material of the balloon proved to be firmer than usual, so that it could not be inserted into the working cannula.With another balloon, this was then achieved without any problems.

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.H3, h6: part #: 03.804.701s; synthes lot #: j002425; supplier lot #: 82209258; release to warehouse date: 22 jan 2021; expiration date: 01 dec 2022; supplier: (b)(4).No ncr's 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.Visual inspection: the synflate vertebral balloon med (pn: 03.804.701s, synthes ln: j002425, confluent medical technologies ln: 82209258) was received at us customer quality (cq).Visual inspection of the complaint device showed some loose crystallized substance inside the balloon, but no other issues or damage on the device.Functional test: a functional assessment was unable to be performed on the complaint device due to lack of mating devices.The complaint was not able to be replicated.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed synflate catheter packaging tray; synflate catheter assembly.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed for the synflate vertebral balloon med (pn: 03.804.701s, synthes ln: j002425, confluent medical technologies ln: 82209258) as no damage or issues were observed that would contribute to the complaint condition, and a functional test was unable to be performed.However, there was some unknown substance inside the balloon.No definitive root cause could be determined based on the provided information.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.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: SYNFLATE BALLOON/MEDIUM- STERILE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11975939
• MDR Text Key: 255422326
• Report Number: 8030965-2021-04775
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819525399
• UDI-Public: (01)07611819525399
• Combination Product (y/n): N
• PMA/PMN Number: K130146
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 03.804.701S
• Device Lot Number: J002425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1