MAUDE Adverse Event Report: S.B.M. SAS COMPOSITE SCREW LIGAFIX 60 DIAM. 9 - L:25 MM; INTERFERENCE SCREW

Catalog Number COM6009025

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Retrospective review after expertise report: direct analysis on returned device: the screw broke into at least two pieces.One of these pieces was returned to sbm it includes the head of the screw.External diameter 9.0 mm - root diameter: 6.3 mm piece length: minimum of 13.0 mm / maximum of 14.3 mm.The fracture occurred in the cylindrical portion.The threads are free from damage.The head and recess are also free from damage.Test insertion with a ø 9 screwdriver into screw head recess is ok: test carried out with ligafix screwdriver ø9 / 10/11 lot 162360.The tcp granules are clearly visible.Conclusion: the injection conditions were compliant with our specifications.The shape and position of the screw breakage are indicative of a torsional breakage.In the absence of several elements surrounding the circumstances of the screw breakage, the hypothesis that can explain this breakage is as follows: while the screw was being driven, the screw took a divergent trajectory from that of the tunnel, causing significant flexural and torsional stresses within the root of the screw, especially when the screw was traversing the cortical wall, and when the cone of the screw head was inserted in the tunnel.These constraints led to a deformation of the screw recess, which is almost zero at the bottom of the recess and maximum at the head of the screw.The deformation of the screwdriver was then greater than the elastic limit of duosorb (the constituent material), which caused 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.He retain a piece of fractured screw.Very low biological risk: excess resorbable material.Mechanical risk: the piece of screw can be an obstacle for the new screw, which can generate a new breakage.The injection conditions comply with our specifications.No corrective action.This file is now closed.

Event Description

Fnc (b)(4) - retrospective review after expertise report.Incident occured on (b)(6) 2019 - transmitted on (b)(6) 2019 by distributor for regularization - incident report received on 08 november 2019: "the screw was broken during surgery".

• Brand Name: COMPOSITE SCREW LIGAFIX 60 DIAM. 9 - 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: 9842354
• MDR Text Key: 221030696
• Report Number: 3004549189-2020-00002
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: COM6009025
• Device Lot Number: 184695
• 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: 12/08/2013
• 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