MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW

Catalog Number	03.52.323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 20 july it was added the lot of the instrument is unknown.On 26 july 2018 the r&d project manager made the following analysis: difficulty to engage the set screw into the pedicle screw head (tulip), after rod reduction.The issue is confirmed by attempting to place the set screw without the rod.The issue can be caused by a defect of the thread of the tulip.However the same thread is used to couple the screw to the pedicle screwdriver at the first steps of the surgery, therefore the thread cannot have been defective from the beginning.The defect/deformation could have occurred during the reduction manoeuvre/first attempt to engage the set screw.Or the defect can be on the set screw.Detailed analysis will be performed with the devices as soon as available.On 27 july 2018 the medical affairs director made the following analysis: during a percutaneous lumbar posterior stabilization surgery, difficulty was encountered placing the set screw on one of the l5 pedicle screws, which was therefore removed and exchanged.No further problem was encountered.We do not think that the cause for this inconvenience can be of clinical origin.No clinical consequence should be expected apart from the surgery being lengthened by approximately 30 minutes, according to the report.Batch review performed on 30 july 2018: lot 1721554: (b)(4) items manufactured and released on 08 june 2018.Expiration date: 2023-04-05.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.The set screw lot has been checked too: (b)(4) items released, with no anomalies related to the issue.
Event or Problem Description
When the surgeon was trying to insert the set screw into the pedicle screw head which was already implanted at l5, it was not able to insert, even though the surgeon used the reducer.Then he tried to insert without the rod, but it was not able.Since it was doubtful whether the issue was with pedicle screw head or percutaneous tower, the pedicle screw was replaced with a more large size.The surgery was performed by pps and finished successfully.Due to this event the surgery was prolonged about 30 minutes.
Additional Manufacturer Narrative
Visual inspection performed the 28th of september on pedicle screw and setscrew by r&d product manager: both implant components look intact and functional.The setcrew can be easily inserted in the pedicle screw head, in both direction.It can be excluded that the event is caused by a defect/damage on the implants.It is possible that the event is related to a defect/damage of the related instrument (e.G.Percutaneous tower 03.52.10.0521 if used) or to a wrong manouvre.

• Brand Name: MUST PEDICLE SCREW
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734728
• Report Number: 3005180920-2018-00597
• Device Sequence Number: 752245
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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
• Operator of Device: No Information
• Device Expiration Date: 04/05/2023
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1721554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 64