MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (6X)

Catalog Number	03.50.206
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the visual inspection has been performed on: pedicle screw 7x50, ref.(b)(4), lot.1820673.Must combined set screw - (6x), ref.(b)(4), lot.1820486 (3 pcs).Must combined set screw - (4x), ref.(b)(4), lot.1820860 (4 pcs).The lot.1820673 has the pedicle head with a clear damaging of the thread, particularly on one side.All the pcs of the lot.1820486 have damaging of the thread.In particular, one screw, indicated in the picture with an arrow it's particularly damaged.The lot number is difficult to read due to the wearing but visible on the microscope.It's not possible to use any kind of temporary set screwdriver on it.All the pcs of the lot.1820860 have damaging of the thread.The root cause of the event is probably due to a cross-threading of the pedicle screw, lot 1820673, with the set screw, lot 1820486.This event has damaged the tulip thread and the set screw.All the damaging of the set screw occurred after this event is due to the damaged interface of the tulip.Batch review performed on 12 march 2019: lot 1820486: (b)(4) items manufactured and released on 15-jun-2018.Expiration date: 2023-05-23.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.The current case involved 3 pieces of this lot.Additional components involved: pedicle screw (b)(4) must combined set screw h4-t27 - (4x), ((b)(4)) lot 1820860: (b)(4) items manufactured and released on 15-jun-2018.Expiration date: 2023-05-23.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.The current case involved 4 pieces of this lot.Pedicle screw (b)(4) pedicle screw 7x50 ((b)(4)), lot 1820673: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-04-29.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.
Event or Problem Description
After implanting the pedicle screws, it was difficult to fix the rod on the left side.When the cage on l5-s1 was inserted, the surgeon tried to perform some compression force on the segment, at this time, when they tried to fix the combined set screw, 2 threads of 2 set screws have been broken.The surgery has been completed successfully using a new rod, deformed a little bit more and new set screws.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (6X)
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8416467
• Report Number: 3005180920-2019-00144
• Device Sequence Number: 277760
• Product Code: NKB
• UDI-Device Identifier: 07630040717069
• UDI-Public: 07630040717069
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 03/13/2019

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: 05/23/2023
• Device Catalogue Number: 03.50.206
• Device Lot Number: 1820486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/13/2019
• 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