MAUDE Adverse Event Report: S.B.M. SAS ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 9 MM - LG 30 MM

Catalog Number COM6009030

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/13/2015

Event Type  malfunction  

Manufacturer Narrative

For regularization - retrospective review / fda request.This batch of screw presents no manufacturing defect.Everything conforms to specifications.Given the progress of the manufacturing session of this batch, its implementation conditions can not be at the origin of these two failures.Screw no.1 : damaged nets and sheared tip.The observation of the screw reveals a damage of the nets present on the cone of entry.The nets played their role of fuse, avoiding the rupture of the soul of the screw.In view of the damage of the nets, we believe that the tunnel bore diameter was less than 9mm, the maximum diameter found at the level of the damage of the nets not exceeding 6.5mm.We explain this damage by difficulties encountered by the surgeon in introducing the screw into the tunnel in the presence of a very hard bone and an insufficient drilling diameter.The nets stumbled against the cortical bone, and the surgeon's insistence on advancing the screw into the tunnel caused shearing of the threads in contact with the cortical bone.As soon as the threads of the entry cone were damaged, the screw had lost all bite and could not progress.In the presence of high density bone, we recommend the use of the appropriately sized tap.Screw no.2 : broken in 2 pieces.We do not have enough evidence to conclude on the reason (s) that led to the breakage of this screw.The type of fracture of this screw is characteristic of a torsional rupture.The absence of damage to the threads, the apparent insertion length of the screw and the insufficiency of the information communicated allow us to consider several hypotheses: hypothesis 1: a tibial tunnel drilled to 9mm, a ø9 graft very "press fit" completely obstructing the tunnel, a patient with a high bone density and the presence of a significant radial clearance between the footprint of the screw and the screwdriver at the beginning of the cylindrical portion of the screw in the tibia, significant stresses that have reached a level above the elastic limit of the duosorb 60, resulting in the rupture of the screw in torsion.Hypothesis 2: the tibial tunnel was drilled to a diameter <9mm.A tunnel of too small diameter compromises the penetration of the screw.At the beginning of the cylinder portion of the screw in the tibia, the stresses in the core of the screw reached a level above the elastic limit of the duosorb 60, resulting in the rupture of the screw in torsion.Phenomenon that can intervene prematurely in the presence of a significant radial clearance between the impression of the screw and the screwdriver.

Event Description

(b)(4)- for regularization - retrospective review / fda request.2 screw broke while being implanted.

• Brand Name: ROUND HEAD INTERFERENCE SCREW LIGAFIX 60 Ø 9 MM - LG 30 MM
• Type of Device: INTERFERENCE SCREW
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, france 65100 ; FR 65100
• Manufacturer Contact: regine bareilles ; zi du monge; lourdes, france 65100 ; FR 65100
• MDR Report Key: 8603063
• MDR Text Key: 160318115
• Report Number: 3004549189-2019-00071
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2017
• Device Catalogue Number: COM6009030
• Device Lot Number: 143567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other