MAUDE Adverse Event Report: SYNTHES SELZACH ACCESS KIT 10 GAUGE-BEVEL TIP END-OPENING-STERILE; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY

Catalog Number 03.804.518S

Device Problem Bent (1059)

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

Event Date 10/20/2014

Event Type  malfunction  

Event Description

It was reported that during an l3 surgical procedure involving vba (vertebral body augmentation)instrumentation, and the synflate access kit-beveled tip opening, the surgeon initially had difficulty getting the bevel tip to stay locked to the working cannula.It came unlocked very easily, and caused an additional delay of 5 to 10 minutes in accessing the pedicle.The surgeon then removed the working cannula and bevel tip, and then realized the bevel tip had bent backward.A new bevel tip was opened, and the procedure was completed without further problem.Swapping out of working cannula/needle, because it was bent, caused an additional 5 minutes.Total delay in surgery was reported to be 10-15 minutes.There were no adverse consequences to the patient and the patient was not exposed to additional anesthesia.This complaint involves 1 device.This complaint for one access kit - beveled tip.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: lxh.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and during the manufacture of the product no complaint related issues were found.No ncrs were generated during production.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing investigation was conducted.The report indicates that all material meets the specification.When the device met a hard surface with enough force the result is a backward bend tip.Root case is happened after opening the blister and before or in use of the device in the procedure.No action planned.The supplier has seen there was a bent on the device.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: ACCESS KIT 10 GAUGE-BEVEL TIP END-OPENING-STERILE
• Type of Device: CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4245221
• MDR Text Key: 5045208
• Report Number: 3000270450-2014-10148
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 03.804.518S
• Device Lot Number: 13K07-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• 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: 73 YR