MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T PEDICLE SCREW 6X45

Catalog Number 03.50.018

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2015 the r&d manager performed a preliminary investigation for pedicle screw which showed potential cross-threading of the setscrew on the pedicle screw head (tulip).The setscrew needed to be properly aligned to the tulip during in-situ assembly, to allow proper construct finalization.Instruments were provided in the set to allow the correct alignment in complex cases (e.G.Set screwdriver enhanced 03.51.10.0128, one step reducer 03.51.10.0114).On 01 dec 2015 the r&d manager visually inspected the retrieved item with the following comments: the inner thread of the pedicle screw head (tulip) appeared heavily damaged, suggesting an event of cross threading as described in the preliminary investigation.Mis-alignment could occur during the initial positioning of the setscrew, but the screw got damaged during the final tightening.Before proceeding with the final tightening, the surgeon could verify the correct alignment of the setscrew.Provided the available instruments, this type of cross threading and screw damage could be addressed as user error.Batch review performed on 16 december 2015: lot 155052: (b)(4) items manufactured and released on 11 sep 2015.Expiration date: 2020-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

Thread of the screw was damaged during insertion of the set screw.The surgeon was present during the surgery and replaced the screw with no consequences for the patient.

Manufacturer Narrative

On 19 february 2016 it was prepared a final report with the information already submitted in the initial report.On 18 march 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: M.U.S.T PEDICLE SCREW 6X45
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5322903
• MDR Text Key: 34924277
• Report Number: 3005180920-2015-00337
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K121115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: 03.50.018
• Device Lot Number: 155052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 90