MAUDE Adverse Event Report: S.B.M. SAS COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM; INTERFERENCE SCREW

Catalog Number COM6008025

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Retrospective review after expertise report - for regularisation.Direct analysis on returned device: the screw was broken in at least two pieces.One of those was returned to sbm, it comprises the screw head.External ø 7.9 mm, diameter of cylinder (minor diameter) could not be measured.Length of piece: minimum of 8.8 mm and maximum 13.2 mm.The fracture occurred at the birth of the cone of the screw head.The thread adjoining the fractured area is damaged: it was completely sheared along 1/4 turn of the thread.The thread is bent backward over the 2nd 1/4 adjoining the sheared portion.The remaining threads of the screw are free from damage.The head and recess are also free from damage.The screwdriver insertion test (with a ø7-8 screwdriver) was ok: test carried out with ligafix screwdriver ø7 / 8 lot 090416.The tcp granules are clearly visible.Conclusion: observation of the screw reveals a torsional fracture at the birth of the cone of the head.In the absence of many elements surrounding the circumstances of this screw breakage and in view of the observations made on the latter, the hypotheses that can explain this breakage are listed below: non-compliance with the instructions for use with a tunnel ø < than the screw ø, which generated high friction forces over the entire surface of the screw during the passage of the cortical wall.All of these constraints have caused a deformation of the recess.The deformation was almost zero at the bottom of the recess and at its maximum at the head of the screw.The deformation of the screwdriver is then greater than the elastic limit of the duosorb, causing the screw to break.The screw was not inserted perfectly within the axis of the tunnel.The entry cone of the screw was jammed against the cortical bone, the continued driving force deformed the cylindrical portion of the screw which was driven by the screwdriver, causing torsional stresses at the junction of the cylindrical area with the screw head.The cylindrical area of the screw being blocked, the torsional stresses were then greater than the elastic limit of the duosorb, causing the screw to break.Combination of hypotheses 1 and 2 inevitably causing the screw to break.The same event would be likely to cause or contribute to serious injury because the medical device fractured while in the patient and he retain potentially a piece of fractured screw (depending on the piece of screw returned).Mechanical risk: the piece of screw can be an obstacle for the new screw, which can generate a new breakage - risk of debris coming out of the tunnel into the joint.Very low biological risk: excess resorbable material.The injection conditions comply with our specifications for the device.Technical sheet with characteristics of resorbable screws was transmitted on 27 may 2020 to the distributor for reminder.Our export area sales manager keeps in touch to identify possible improvement points on the surgeon's technique and to follow up with the technical sheet.

Event Description

(b)(4) - retrospective review after expertise report - for regularisation.Incident occured on (b)(6) 2019 - transmitted on 07 november 2019 by distributor."the screw was broken during surgery".

• Brand Name: COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 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: 10148078
• MDR Text Key: 225940840
• Report Number: 3004549189-2020-00012
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K122228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: COM6008025
• Device Lot Number: 183005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2018
• 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