MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REDUCTION PEDICLE SCREW 7X50

Model Number	03.50.732
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31 may 2021 lot 1720742: (b)(4) items manufactured and released on 31-oct-2017.Expiration date: 2022-10-10.No anomalies found related to the problem to date, (b)(4) item of the same lot has been already sold without any other similar reported event preliminary investigation performed by r&d project manager: from the pictures received with the complaint, it's clearly visible that one side of the thread of the pedicle screw head is broken, damaged.The event, popping of the setscrew, better described in the additional description of the event, could be associated to the not complete tightening of the setscrew into the pedicle screw head.In particular, if approximately less that 2 pitch (2mm) of the thread are in contact before the removal of the tabs, this failure can occur.For this reason, the event could be assocated to a premature removal of the tab before the setscrew was fully seated inside the pedicle screw head, like described in the related surgical technique.
Event or Problem Description
During the primary spine case when the surgeon inserted the must pedicle screws from t08 to s02 using the myspine guides, the rod to connect all the screws, and the set screw into each screw, during final tightening, one of the screw flange (containing the rod and set screw) deformed and a fragment of the tulip popped off the screw shaft.The surgeon had to remove the set screws, removed the rod, removed the affected screw, replaced the broken screw.There was a 1 hour and 30-minute delay and additional anesthesia was administered.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d department: from the pictures enclosed in the complaint it appear that there was a breakage/deformation of the last pitch of thread.This breakage could be compatible with a cross thread of the set screw.The main route cause of this crossthread could not be defined in a clear way.
Additional Manufacturer Narrative
Batch review performed on 31 may 2021: lot 1920266: 50 items manufactured and released on 22-feb-2019.Expiration date: 2024-02-10.No anomalies found related to the problem.To date, 35 item of the same lot has been already sold without any other similar reported event.

• Brand Name: REDUCTION PEDICLE SCREW 7X50
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11912724
• Report Number: 3005180920-2021-00451
• Device Sequence Number: 3426069
• Product Code: NKB
• UDI-Device Identifier: 07630030846977
• UDI-Public: 07630030846977
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2021

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: Health Professional
• Device Expiration Date: 02/10/2024
• Device Model Number: 03.50.732
• Device Catalogue Number: 03.50.732
• Device Lot Number: 1920266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 05/03/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/07/2021; 08/03/2021
• 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