MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)

Catalog Number	03.50.031
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the lot of the broken screw is unknown it is reported in the mdr all the possible lot involved.Lot 165548: (b)(4) items manufactured and released on 28 november 2016.Expiration date: 06.11.2021.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.Reference 03.50.031 (k121115) pedicle screw 7x45: lot 1721021: (b)(4) items manufactured and released on 22 february 2018.Expiration date:2023-02-06.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.Reference 03.50.030 (k121115) pedicle screw 7x40: lot 1721195: (b)(4) items manufactured and released on 18 january 2018.Expiration date: 2023-01-03.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.Reference 03.50.061 (k132878) pedicle screw 8x75mm lot 152328: (b)(4) items manufactured and released on 29 may 2015.Expiration date: 2020-04-22 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.Visual inspection performed on 27th of june, 2018.A small piece of the setscrew (the first thread) detached from the setscrew.Potential cross threading of the setscrew (wrong engagement of the thread) might have resulted in damage of the setscrew during final tightening.Cross threading is a rare event that can occur with every pedicle screw system.Instruments are provided in the set to ensure the correct alignment and engagement of the setscrew (e.G.Enh.Setscrewdriver 03.51.10.0128; one step reducer 03.51.10.0181; countertorque 03.51.10.0064).The surgeon is usually able to notice if cross threading occurred by a significant friction/tigthening force, and in such case he can remove and reposition the setscrew in the pedicle screw.Even in case of cross threading, damage to the setscrew and/or to the pedicle screw head is very unlikely.Internal tests have been performed to reproduce such event (cross threading+final tightening) and in no case a breakage of the setscrew similar to the pictures reported with this complaint occurred.Events of thread breackage as presented in the complaint, might be alternatively related to a different manoeuvres, such as hammering of the setscrew against the tulip.
Event or Problem Description
Set screw (specific lot unknown) has been broken during tightening, small pieces remained in the patient's wound.The set screw was replaced with a new one.When the surgeon tightened the set screw after implantation of the pedicle screw 7x40 at l5, he discovered the set screw was broken.He removed the broken piece of the set screw, but small pieces (2 mm) remained in the patient body.The set screw was replaced with a new one, the surgeon decided to not retrieve the small pieces that remained the patient.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 7X45 (2 PCS)
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7662373
• Report Number: 3005180920-2018-00481
• Device Sequence Number: 11167505
• Product Code: KWP
• UDI-Device Identifier: 07630030834295
• UDI-Public: 07630030834295
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 11/06/2021
• Device Catalogue Number: 03.50.031
• Device Lot Number: 165548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/04/2018
• 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: 72 YR