MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X); SCREW FOR CERVICAL PLATE

Catalog Number	03.70.155
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 january 2018: lot 141367: (b)(4) items manufactured and released on 22 october 2014.Expiration date: 2019-09-30.No anomalies found related to the issue.To date, (b)(4)items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During a c5-c7 acdf one of the screws broke upon final tightening.The surgeon was able to recover the full screw from the patient.The surgeon used a secondary screw to complete the surgery.There was no delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed on 15th february 2018 by r&d department: during the visual inspection it was observed and confirmed that one out of four prongs was broken at the base as per fragile fracture.This kind of failure is likely due to high stress generated at the implant-instrument interface because of uncorrect alignment as well as not preparation of the screw pilot hole.In order to ease the positioning of screw, dedicated instrument like tap were introduced on the market to properly prepare the pilot hole.Additionally, in order to avoid the risk of misalignment at the screw-screwdriver interface , a newest rigid screwdriver was introduced on the market as from july 2016.This screwdriver is aimed to rigidly secure the bone-screw on the driver tip and, therefore, avoid the risk of misalignment ang toggle at the implant-instrument interface.However, we have not evidence which kind of technique was performed to position the screw (pilot hole preparation and/or usage of modular rigid screwdriver).

• Brand Name: FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X)
• Common Device Name: SCREW FOR CERVICAL PLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7166916
• Report Number: 3005180920-2017-00818
• Device Sequence Number: 10996302
• Product Code: KWQ
• UDI-Device Identifier: 07630030840920
• UDI-Public: 07630030840920
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• 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,Followup
• Report Date (Section B): 02/16/2018

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: 09/30/2019
• Device Catalogue Number: 03.70.155
• Device Lot Number: 141367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/16/2018
• 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