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

Catalog Number	03.30.10.0013
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 1552537: (b)(4) items manufactured and released on 29-mar-2016.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Visual inspection performed by r&d (b)(4): the alif tap has been broken during implantation with an alif cage and an alif plate.The instrument is broken in two parts, the tip remained inside the patient's vertebral body.The part analyzed is according to the event described.The tip of the tap is broken.The hardness of the part failed during surgery has been analyzed, the hardness is compliant to the specifications.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).Clinical evaluation performed by (b)(4): during lumbar stabilization anterior surgery the tip of the tapping instrument broke off and remained in the patient's bone.The remaining screws could be inserted regularly.The cause of this event is not of clinical origin.The broken tip embedded in bone is made of a surgical grade stainless steel, however not validated for long term implantation, but given the location the chances that an adverse event takes place are extremely small.The stability of the construct may still be totally satisfactory.Moreover, posterior stabilization was scheduled, so we do not expect any negative clinical consequence from the lack of one screw.
Event or Problem Description
During the vertebra tapping, in the anterior surgery, the tip of the instrument broke off.The broken fragment remained in situ and for this the surgeon was able to insert only 3 bone screws.9 days after primary surgery the surgeon performed a second surgery to insert the posterior stabilization implants.The surgery was completed anyway successfully.

• Brand Name: MECTALIF ANTERIOR ALIF COMPRESSION SCREW
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8486482
• Report Number: 3005180920-2019-00237
• Device Sequence Number: 16398607
• Product Code: LXH
• UDI-Device Identifier: 07630040798396
• UDI-Public: 07630040798396
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/05/2019

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: 1552537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/05/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 90