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

Catalog Number 03.804.702S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient weight not provided by reporter.Additional product code: hrx.(b)(4).Device is an instrument and is not implanted/explanted.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 history records was conducted.The report indicates that the: manufacturing location: (b)(4) supplier: (b)(4) 03.804.702s/1014005, manufacturing date: 03.Dec.2014 expiry date: 31.Oct.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a balloon would not fit into the working cannula so it could not be used.The surgeon used a size small balloon and it fit fine.No broken instruments or fragments generated.Additional medical intervention was not required and no surgical delay reported.Patient outcome unchanged due to the event and surgery was completed successfully.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the small synflate balloon (03.804.702s) is a component of the synflate system which is a balloon-based vertebral augmentation system utilized for vertebral compression fractures and osteolytic lesions.The system technique guide notes the following regarding the reuse the balloon catheter: the synflate balloon catheter may be reused once within the surgery.For balloon catheter reuse, remove the inflation system and carefully insert the catheter back into the white cover sleeve to properly refold the balloon.Since the first inflation may stretch the balloon material, the length may become larger than the original length.Therefore always insert the catheter under fluoroscopic control.Relevant drawings for the returned devices were reviewed.The design and materials were found to be appropriate for the intended use of these devices and changes to sequent revisions were unrelated to the complaint condition.A device history review was performed for the returned instrument¿s lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.Upon inspection of the returned instrument, debris could be seen in the balloon indicating that the balloon was most likely used at least once.However, the complaint condition cannot be replicated without the holding sleeve so the complaint cannot be confirmed.No definitive root cause could be determined based on the complaint description however there is a chance that the proper procedures for reuse were not followed.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: SYNFLATE BALLOON/LARGE-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: 5564348
• MDR Text Key: 42269510
• Report Number: 3000270450-2016-10088
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 03.804.702S
• Device Lot Number: 1014005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2014
• 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 Age: 60 YR