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

Catalog Number	03.30.10.1050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: lot 1654882: (b)(4) items manufactured and released on 27 february 2017.No anomalies found related to the issue.To date, another similar event has been registered on the same lot ((b)(4)).Clinical evaluation performed by medical affairs director: intraoperative fracture of an awl during bone preparation.This resulted in a 3-screw construct, whose stability we cannot assess.The potential danger of a small fragment of awl embedded in the bone is minimal, although the awl material is not approved for long-term implantation.The surgeon decided not to proceed with bone damaging in order to retrieve the broken fragment and this was most probably a wise choice given the situation.We do not anticipate any major compromise on the clinical result of this surgery.Preliminary investigation performed by r&d project manager: from the pictures enclosed in the complaint and the description of the event, it's possible to see that the tip of the awl straight (ref.03.30.10.1050 lot.1654882) has been broken in one of the holes of the plate and it remains into the vertebral body.The potential root cause of the event it's probably due to the application of lateral bending on the instrument.
Event or Problem Description
The tip of awl instrument broke off whilst in use.The tip remained embedded in patients bone.It was not possible to place the screw because of the awl fragment.The construct have now 3 screws instead of 4.The instrument comes from a loan set.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the part analyzed is according to the event described.The tip of the awl is broken.Internal test / verifications: the distance from the edge of the tip to the mechanical stop of the sleeve 68.19.051 (40mm in the not broken part) is 30mm, the missing tip length is approximately 10mm.The hardness of the part failed during surgery has been analyzed, the hardness is compliant to the specifications.Root cause hypothesis: according to the shape of the fracture surface and to the fact that the external sleeve (68.19.065) is not damaged, the root cause of the failure could be the excessive lateral bending applied to the instrument while the external sleeve (68.19.051) is not completely engaged in the recess of the plate.Additional information: in cases such this, an instrument with a universal joint should be used to avoid the bending of the tip.Awls with universal joint are already present in medacta instrumentation (ref.03.30.10.1060 and 03.30.10.1610).

• Brand Name: MECTALIF ANTERIOR ALIF AWL STRAIGHT
• 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: 8443626
• Report Number: 3005180920-2019-00180
• Device Sequence Number: 11510567
• Product Code: LXH
• UDI-Device Identifier: 07630040796965
• UDI-Public: 07630040796965
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/17/2019

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: 03.30.10.1050
• Device Lot Number: 1654882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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