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

Catalog Number 03.804.702S

Device Problem Difficult to Insert (1316)

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

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: may 28, 2015.Expiry date: march 01, 2017.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported the surgeon had issues with the synflate balloon.A 10g access needle, tamp, drill (due to hard bone), a large 20mm balloon, and vertecem cement were used.Surgeon had a really hard time pushing the large balloon down the working cannula after he drilled.After five (5) minutes of fighting with the balloon, and changing gloves to get a better grip, surgeon finally was able to insert the balloon into the cannula and then into the vertebral body.There was a five minute surgical delay; the procedure was successfully completed.This is report 1 of 1 for com-(b)(4).

• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5504248
• MDR Text Key: 40460987
• Report Number: 3000270450-2016-10065
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 03.804.702S
• Device Lot Number: 0415013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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 Age: 59 YR