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

Catalog Number	03.50.204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 november 2018: lot 1820484: (b)(4) items manufactured and released on 08 june 2018.Expiration date: 2023-05-23.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.Pedicle screw one-step reducer enhanced (surgical instrument): lot 1850416: (b)(4) items manufactured and released on 27 june 2018.No anomalies found related to the problem.To date, no similar event on the same lot has been registered.Preliminary investigation performed by r&d product manager on november 21, 2018: deformation and delamination of the thread start of the set screw during "insetion" on the pedicle screw head tulip.Similar failure could be theoretically related to cross-threading and/or wrong "alignement" between set screw and tulip.However, based on the event description, the one-step reducer 03.51.10.0181 was used; therefore, cross-treading is unlikely.Also the pictures show that at the end of the tightening the set screw is well placed, no cross-threading or "misalignement".Another cause of this issue could be the presence of burrs or sharp edges at the beginning of the thread - production defect.In this case, the set screw needs to be removed and replaced with a new one, available as spare part in the implant kit.
Event or Problem Description
During a l5-s1 fusion surgeon used the one step reducer to reduce the rod into the screw head.This went well; set screw went in without friction.For one of the set screw reduction counter-torque and torque limiter were used to final tighten the construction under compression.After this maneuver, the surgeon did a last check inside and he saw a stripped thread from the set screw that stuck outside the tulip.The set screw was removed "an" swapped with a new one without critical delay.
Additional Manufacturer Narrative
Visual inspection performed december the 18th, 2018.The provided images have been considered for the inspection.The following surgical steps have been done by the surgeon: rod reduction and setscrew temporary locking using 1-step reducer, final tightening by means of countertorque and torque limiter.After these steps, it was noticed a stripped thread of the setscrew.Looking at the images, the damaged thread seems the lowest or one of the lowers.A potential root cause could be that it was partially damaged during the maneuvres prior to screw-tulip correct engagement, and then finally stripped when the 9nm torque was apllied with the torque limiter.The 1-step reducer received (ref 03.51.10.0181) doesn't have a compromised functionality and has been successfully used for rod reduction and setscrew temporary locking on a sawbones.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 -
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8099787
• Report Number: 3005180920-2018-00942
• Device Sequence Number: 2035320
• Product Code: NKB
• UDI-Device Identifier: 07630040716086
• UDI-Public: 07630040716086
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 01/03/2019

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: 03.50.204
• Device Lot Number: 1820484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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