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

Catalog Number	03.50.206
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 1920448: 100 items manufactured and released on 15 february 2019.Expiration date: 2024-02-04.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.Visual inspection performed on 11 july 2019: pictures attached to the complaints has been taken in consideration during the visual inspection.The set screw (ref.03.50.206, lot.19205448) is broken and a part of the thread is damaged.The functionality of the set screw is compromised.The potential root cause of the damaging is the cross threading with the pedicle screw head due to a probably misalignment between the two components.Additional information: different instrument are available in the must standard set or on demand to aim the surgeon during the set screw placement (i.E.One step reducer, two step reducer, locking tower, enhanced set screw driver).
Event or Problem Description
The set screw broke during insertion into the tulip.It has been replaced, and the two fragments were removed from the patient.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (6X)
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8783962
• Report Number: 3005180920-2019-00561
• Device Sequence Number: 19417775
• 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): 07/12/2019

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: 02/04/2024
• Device Catalogue Number: 03.50.206
• Device Lot Number: 1920448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/12/2019
• 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