MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 15MM SHORT - PEDICLE SCREW Ø7X35 CANN

Catalog Number	03.57.033
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon broke must lt screw tab after the final fixation of the set screw at s1, but one tab did not break correctly.The remaining tab was broken with a plier after additional cuts.Delay time was about 30 min and total surgery time was about 3 hours.
Additional Manufacturer Narrative
Batch review performed on 5 january 2024 lot 2227030: 50 items manufactured and released on 12-oct-2022.Expiration date: 2027-sep-25.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported event during the period of review.Preliminary investigation performed by r&d project manager: according to picture received, the tab broke in correspondence of the welding between the tab of the tulip and the extension.It is unknown if the event has been caused by an issue in the welding, a misfunction of the tab breaking instrument, or a suboptimal placement of the instrument itself.According to our procedures, the first piece of each batch has to be tested to verify the resistence of the welding and ensure correct manufacturing parameters.No further analysis can be performed with the data available at the moment.Additional implants involved, batch review performed on 5 january 2024: must lt 03.57.033 must lt 15mm short - pedicle screw ø7x35 cann (k203482) lot 2227767: 40 items manufactured and released on 02-nov-2022.Expiration date: 2027-oct-12.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event during the period of review.Must lt 03.57.033 must lt 15mm short - pedicle screw ø7x35 cann (k203482) lot 2228694: 50 items manufactured and released on 05-jan-2023.Expiration date: 2027-dec-11.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Must lt 03.52.10.0742 break off tab lot 2258744: 50 items manufactured and released on 05-apr-2023.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Additional Manufacturer Narrative
On (b)(6), 2024 we have received the instruments involved in the complaint.Visual inspection performed by r&d project manager: both instruments have been tested on a must lt screw and broke the tabs in the correct way.Regarding the implant, it is unknown which one of the 3 indicated batches is involved.Despite this, among the 3 batches, almost the 50% of the screws have been already sold without other issues reported.Must lt tulip is made of a main body to which the long tabs are welded: according to instructions of work, the first piece of each batch has to be tested to verify the resistence of the welding and ensure correct manufacturing parameters.In addition, the welding process is completely automate, eliminating the risk of human error during manufacturing.The fact that one of the tabs of the tulip broke in the wrong point, while the other broke correctly, eliminates the probability of welding related issues.

• Brand Name: MUST LT 15MM SHORT - PEDICLE SCREW Ø7X35 CANN
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18543624
• Report Number: 3005180920-2023-01110
• Device Sequence Number: 9080474
• Product Code: NKB
• UDI-Device Identifier: 07630971278448
• UDI-Public: 07630971278448
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (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): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.57.033
• Device Lot Number: 2227030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian