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

Catalog Number 03.804.520S

Device Problems Bent (1059); Mechanical Jam (2983)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 the end of a beveled tip access needle was bent during an unspecified spinal surgical procedure on (b)(6) 2016.The beveled tip access needle comes locked inside a cannula.The surgeon hammered the access needle inside the cannula as it was placed in the patient's left pedicle.When the access needle was being removed from the cannula after it was embedded in the pedicle, the needle could not be pulled up.It moved approximately 1 centimeter.After twisting the needle back and forth it was discovered that the needle was stuck inside the cannula.The surgeon decided to hold the cannula down with one hand while prying the beveled access needle out of the cannula.He was finally able to get the access needle out.The surgeon inserted the access needle into another cannula.This was when it was discovered that the issue was with the access needle; the end of the beveled tip was bent.There was approximately a five minute delay in surgery due to the reported event.The surgery was successfully completed with no harm to the patient.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

A product investigation was completed: upon inspection of the returned instrument, the complaint was able to be confirmed the tip of the beveled trocar was bent outwards.There was significant resistance passing the trocar through the working sleeve.Based on the given information, the definitive root cause could not be determined.However, it is possible that rough handling of the instrument and mechanical overload (compression force) that exceeded the load limit contributed to the led to the complaint condition.Per the technique guide, the beveled tip 10g access kit is a component of the synflate system which is a balloon-based vertebral augmentation system utilized for vertebral compression fractures and osteolytic lesions.The access kit comes with a working sleeve (commonly referred to as a cannula) with a trocar, a plunger, and an injection needle.The trocar allows for transpedicular or extrapedicular access in a single step.The sleeves are marked with equidistant depth markers to allow monitoring of the insertion process.If necessary, the blue handle of the trocar can be gently hammered to advance the trocar instrumentation.The relevant product drawings were reviewed during the investigation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The beveled trocar and the working sleeve of the 03.804.520s access kit were returned for investigation.The working sleeve was returned in good condition but the tip of the beveled trocar was bent outwards.There was significant resistance passing the trocar through the working sleeve.Based on the given information, the definitive root cause could not be determined.However, it is possible that rough handling of the instrument and mechanical overload (compression force) that exceeded the load limit contributed to the led to the complaint condition.The design is adequate for its intended use when used and maintained as recommended, it did not contribute 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: ACCESS KIT 10 GAUGE-BEVEL TIP SIDE-OPENING-STERILE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 5517426
• MDR Text Key: 40934979
• Report Number: 3000270450-2016-10072
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 03.804.520S
• Device Lot Number: 15J14-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 87 YR