MAUDE Adverse Event Report: SYNTHES SELZACH SYNFLATE BALLOON/MEDIUM-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.701S

Device Problem Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient id/initials, age/date of birth, and weight are unknown.Additional product code: hrx.(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Capture extra intra-operative x-rays.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: february 11, 2015.Expiry date: december 01, 2016.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 in (b)(6) as follows: it was reported that during t6/t7 kyphoplasty surgery after balloon inflation, the balloons did not deflate correctly in order to be removed from the working sleeve.The surgery was therefore prolonged about ten (10) minutes.There was no patient harm.The problem was solved by removing both the working sleeve and balloon together instead of the balloon being removed through the working sleeve.This meant that the working sleeve had to be reintroduced for cement introduction.This added time and extra x-ray exposure for the patient.Once this extra step was completed, the operation continued as normal to a satisfactory outcome.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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

A manufacturing evaluation was completed: the balloons were deflated and powdery contrast medium residue was observed in all three balloons.It was reported that three synflate m instruments did not deflate properly and could not be removed through the working sleeve.The review of the manufacturing history of the three production lots did not reveal any nonconformity.The complaint instruments were manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.During the technical investigation all three instruments could be inflated and deflated without problems.The instruments could hold vacuum and reached a fully deflated state.It seems likely that the root cause for the complaint event is related to external factors during the procedure (e.G.Saline/contrast medium mixture too viscous, not holding vacuum during withdrawal).Complaint is unconfirmed as it was not possible to reproduce the complained malfunction.No manufacturing related issue was identified.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: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5403708
• MDR Text Key: 37302797
• Report Number: 3000270450-2016-10026
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 1114040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention