MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM

Catalog Number 03.52.324

Device Problem Misassembled (1398)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information received on 28 april 2017 and includes: once the surgeon placed 3 of the screws unilaterally, he went to use the reduction driver to engage set screws for distraction and cage placement.He removed the reduction construct and even though the mis reduction driver was completely seated, the set screw would not engage with the tulip and was still on the reduction driver when pulling off the tower even after fiddling with the instrument multiple times.The surgeon was frustrated he could not get reduction or rod placement, so he decided to remove the 3 medacta screws and replace with another company system.Because the systems are not compatible, he had to replace all screws.This was a two-level case where 6 total screws were placed.

Event Description

Once the surgeon placed 3 of the screws unilaterally, he went to use the reduction driver to engage set screws for distraction and cage placement.He removed the reduction construct and even though the mis reduction driver was completely seated, the set screw would not engage with the tulip and was still on the reduction driver when pulling off the tower even after fiddling with the instrument multiple times.The surgeon was frustrated he could not get reduction or rod placement, so he decided to remove the 3 medacta screws and replace them with another company product, the surgery was completed successfully.X-rays and explants are not available.

Manufacturer Narrative

On (b)(4) 2017 the r&d project manager performed a preliminary investigation based on the available information and commented as follows: the surgery was performed in mis (percutaneous) approach.In this case the difficulty to remove the instruments can be related to a deformation/damaging of one or more of the instruments themselves.The root cause can be a defect or wear/tear of the instrument, or incorrect maintenance (e.G.Lubrication) of the instrument set, or wrong/heavy maneuvers.Removal instruments are provided in the set in case of difficult situations.If they are not effective, the surgeon need to remove the implant (pedicle screw) together with the instruments, and replace it with a new pedicle screw mounted to a new instrument (the set contains multiple instruments).The event description has been updated because slightly different in comparison of what was reported in the initial report.Reference and lot number of the instrument involved in this complaint are unknown at this time.Medacta international supposed it is a pedicle screw percutaneous tower inner sleeve (ref.(b)(4)) or a mis pedicle screw percutaneous tower inner sleeve (ref.(b)(4)), but this was not reported from the initial reporter.Lot number of the pedicle screw involved in this complaint is still unknown.Medacta international only knows that 3 different pedicle screws were used during the surgery.The batch review has been performed for all the 3 items on (b)(4) 2017.Must enh.Poly-axial pedicle screw - cannulated 6x45mm, code 03.52.324, lot.164318 lot 164318: 130 items manufactured and released on 22 september 2016.Expiration date: 2021-08-25.No anomalies found related to the problem.To date, 39 items of the same lot have been already sold without any similar reported event.Must enh.Poly-axial pedicle screw - cannulated 6x45mm, code 03.52.324, lot.164295 100 items manufactured and released on 25 july 2016.Expiration date: 2021-07-07.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold without any similar reported event.Must enh.Poly-axial pedicle screw - cannulated 6x45mm, code 03.52.324, lot.163623 150 items manufactured and released on 28 june 2016.Expiration date: 2021-06-08.No anomalies found related to the problem.To date, 52 items of the same lot have been already sold without any similar reported event.

Event Description

The surgeon was able to do the reduction and tighten the set screw but for any reason he wasn't able to remove the instrument.He mentioned that neither before nor after he had such a problem with the system despite of the fact he use the same instruments.He don't has an idea what the root cause could be an considered it as an isolated case.According to him he replaced that screw with a competitor screw which is compatible with 5.5mm rods.

• Brand Name: MUST ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM
• Type of Device: PEDICLE 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
• MDR Report Key: 6593674
• MDR Text Key: 76188859
• Report Number: 3005180920-2017-00268
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141988
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.52.324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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