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

Catalog Number 03.804.701S

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hrx.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 of kyphoplasty of l1 one new synflate balloon was not able to pass through the cannula of the 10 g working sleeve of vertebral augmentation access kit.Surgeon sacrifice to do bilateral approach for the kyphoplasty , only use one balloon for both size kyphoplasty.Surgeon opened two synflate balloon in total, and one of them was able to pass through two working sleeve.Procedure was successfully completed with fifteen(15) minutes delay.This report is for one (1) 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary visual inspection: the synflate vertebral balloon med (part #: 03.804.701s, lot #: 82209258) was received at us cq.Visual inspection of the complaint device revealed that the balloon synflate has a small crack.Functional test: a functional assessment was not perform with the complaint device due to post manufacturing damage.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the visual inspection of the returned device reveal a minor crack on the balloon synflate.Although no root cause could definitively be determined for the reported complaint condition, it is likely that there was a component failure which contributed to the complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part # 03.804.701s.Synthes lot # j002425.Supplier lot # 82209258.Release to warehouse date: 11 dec 2020.Supplier: confluent medical technologies, costa rica.No ncr's were generated during production.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: 12112036
• MDR Text Key: 260107511
• Report Number: 8030965-2021-05510
• 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
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 82209258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1
• Treatment: ACCESS KIT 10 G DIAM TIP SIDE-OPEN DOUBL