MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED (DOUBLE PACKAGING)

Catalog Number 03.30.131

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Additional information received from the initial reporter on 29 october 2016 and includes: the surgeon has used the standard screw driver without torque limiter at the time the failure occurred.He applied a tremendous amount of torque and most likely in the hectic environment not realizing that he wasn't using the torque limiting driver.On 29 october 2016, the r&d director performed a preliminary investigation based on the available information and on the post-operative x-rays, and commented as follows: based on mechanical tests we know that the screw head breaks above 10nm.The torque limiter releases at 5.5nm.Therefore we should have in theory a good safety margin.The screw is fully seated inside the cage and seems at that time point not to create any patient harm.We are going to have a look on the instrument as soon as we will receive it back.Batch review performed on 14 november 2016.Lot 1620156: (b)(4) items manufactured and released on 28 july 2016.Expiration date: 2021-07-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 18 november 2016 the medical affairs director performed a clinical evaluation and commented as follows: screw head fracture during insertion in an alif standalone case.The purpose of this analysis can only be to evaluate the possible consequences of having one headless screw out of 4.Of course, consequences cannot be exactly foreseen.The screw shaft looks correctly placed and therefore it will not hinder device performance and it will help stabilizing the cage during initial settling period, although less efficiently than it would have with an integer head.There is no urgent need to retrieve the broken component, it will not create any harm.The broken head was retrieved and therefore will not be a problem.After few weeks, the cage will be stabilized by the bone fusion process and the screws will not be needed any more.The root cause for this problem can be sought and found by mechanical examination.

Event Description

During surgery when the surgeon was screwing the screw into the metal plate, the screw head broke off.The head did not fall into the patient.The screw head was recovered.The shaft of the screw remained in the patient.The surgery was completed successfully.The screw head is available.

Manufacturer Narrative

On 07 february 2017 the r&d project manager performed a visual inspection and commented as follows: the head of the screw checked was broken just at the end of the center hole ø1.5mm length 3.6mm.The torque to failure of the alif screw is 7.4nm without plate and bigger than 10nm into the plate.An additional test, on similar lots, was performed in order to ensure that there is not a specific decrease of the performance of the screw itself.The results confirm that there are no modification of the screw performance.In addition, according the surgical technique, to perform the final tightening it's necessary to use the torque limiter that can apply a torque of 5.5nm +/- 10% that is enough to guarantee a stable construct.It was reported that the surgeon has skipped the usage of torque limiter and it applied the final tightening torque with free hand.The breakage of the screw happened when the screw was in contact with the plate, as reported in the complaint and shown in the x-ray pictures.In that condition the resistance of the screw head is bigger than 10nm.Due to these reasons, the route cause of the breakage should be the application of a tightening torque higher than 10nm.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED (DOUBLE PACKAGING)
• Type of Device: STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 6112618
• MDR Text Key: 60331884
• Report Number: 3005180920-2016-00595
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K160605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Catalogue Number: 03.30.131
• Device Lot Number: 1620156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other