MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANTERIORLIF ALIF COMPRESSION SCREW; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	03.30.10.0013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the part analyzed is according to the event described.The tip of the tap is broken.Internal test / verifications: the hardness of the part failed during surgery has been analyzed, the hardness is compliant to the specifications.Root cause hypothesis: the root cause of the failure could be the excessive lateral bending applied to the instrument.According to the shape of the fracture surface, the failure mode could not be due to torsion (or axial load due to torsion typical of screw-nut coupling).Batch review performed on 12 march 2019: lot 1410927: (b)(4) items manufactured and released on 26 june 2014.No anomalies found related to the problem.To date, 6 other similar events have already been reported on items of the same lot.
Event or Problem Description
When tapping the pathway for the first screw, the tip of the tap broke off.According to the surgeon no excessive lateral forces were applied.The tip was removed with the help of a kocher forceps.

• Brand Name: ANTERIORLIF ALIF COMPRESSION SCREW
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8412845
• Report Number: 3005180920-2019-00142
• Device Sequence Number: 2327542
• Product Code: LXH
• UDI-Device Identifier: 07630040798396
• UDI-Public: 07630040798396
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 03/12/2019

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 Catalogue Number: 03.30.10.0013
• Device Lot Number: 1410927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/12/2019
• 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