MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X); SPINE PEDICLE SCREW

Catalog Number	03.50.204
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019.Lot 1921204: 150 items manufactured and released on 16-may-2019.Expiration date: 2024-04-27.No anomalies found related to the problem.To date, 96 items of the same lot have been already sold with another similar reported event (second casereported in this same complaint).Additional device involved batch review performed on (b)(6) 2019: pedicle screw 03.50.204 must combined setscrew h4-t27 - (4x) (k171758) lot 1920258: 120 items manufactured and released on 15-feb-2019.Expiration date: 2024-02-05.No anomalies found related to the problem.To date, 82 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The surgeon was not able to insert the 4 out of 3 set screws into the pedicle screw heads due to the crosss-threading, although the surgeon performed the surgery in accordance with the surgical techinique.The surgeon replaced the new set screws.Due to this event the surgery was prolonged about 30 minutes, total surgery time 210 minutes.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d spine product manager: the three setscrew 03.50.204 have the beginning of the thread with a small deformation.The potential root cause of this deformation is due to the cross threading with the pedicle screw head whose risk is more high in the free hand technique.Additional information: in order to reduce the risk of cross threading, it can be used the reduction device (one step reducer / two step reducer / locking tower) or the enhanced setscrew driver.
Event or Problem Description
Devices analysed by medacta r&d.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9171183
• Report Number: 3005180920-2019-00848
• Device Sequence Number: 16853217
• Product Code: NKB
• UDI-Device Identifier: 07630040716086
• UDI-Public: 07630040716086
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171758
• 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): 11/11/2019

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: 04/27/2024
• Device Catalogue Number: 03.50.204
• Device Lot Number: 1921204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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