MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)

Catalog Number	03.30.133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two pieces of the same reference and lot involved in this case.Batch review performed on 05 june 2018: lot 1620158: (b)(4) items manufactured and released on 27 july 2016.Expiration date: 2021-07-17 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 (2 pieces of this lot involved in this case).Preliminary investigation performed by medacta spine r and d manager on the 18th may 2018: we have reviewed the event as well as the different surgical steps with surgeon.First of all the patient had extremely sclerotic bone in particular in l5.Cage implantation as well as screw placement into s1 worked without problems.The issues occurred in l5, they used the awl and drill to prepare the pilot hole.Afterwards they proceed with the screw implantation.The resistance was that high that the screw head broke when the screw was 2/3 implanted.The surgeon mentioned that he was not able to advance the screw with the torque limiter.In addition to that he was not aware of the availability of the tap.The resistance for the second screw was also extremely high which caused the failure.No torque limiter was used because of the high insertion torque.Since he knows that we have a tap he is going to use it for the next case with sclerotic bone.In addition to that we will provide him an instrument with a larger drill diameter that can help as well in these cases.
Event or Problem Description
During the final tightening two screw heads broke.The patient has very sclerotic bone and the surgeon didn't use the torque limiter because he needed an higher torque.The screws were leaved in the patient and the screw heads recovered.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
• Common Device Name: STAND-ALONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7582498
• Report Number: 3005180920-2018-00408
• Device Sequence Number: 217646
• Product Code: OVD
• UDI-Device Identifier: 07630030875434
• UDI-Public: 07630030875434
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 07/17/2021
• Device Catalogue Number: 03.30.133
• Device Lot Number: 1620158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: 40 YR