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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.B.M. SAS COMPOSITE SCREW LIGAFIX 60 DIAM. 9 - L:25 MM; INTERFERENCE SCREW
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S.B.M. SAS COMPOSITE SCREW LIGAFIX 60 DIAM. 9 - L:25 MM; INTERFERENCE SCREW Back to Search Results
Catalog Number COM6009025
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
No incident during manufacturing.Waiting for recovery of the broken screw for expertise.According with the photo transmitted, the patient retain potentially a piece of the fractured screw / potential mechanical risk: risk of debris coming out of the tunnel into the joint.Very low biological risk: excess resorbable material.To complete our investigations, we requested additional information: did the surgeon indicate that the device caused or contributed to serious injury? did the patient retain piece of screw? how did the device fracture? please report on the circumstance when the event occurred.Are there any contributing factors related to the event? if yes, could you explain please? what was used to complete the procedure (part and lot information)? has the surgeon been sensitized / informed following the webinar trainings organized by sbm in 2020? if yes, before or after the date of incident? according with current legislation of your country, is this type of event should be reported to your national competent authority? no other complaint concerning this lot.Actions implemented by sbm: technical sheet with characteristics of ligafix screws was transmitted on 27 may 2020 to the distributor for reminder.Distance training program (impossible travel / covid19) implemented on june 20, in order to readjust the operating techniques and recall the characteristics of each product.Creating a form to check if possible, after surgery, the effectiveness of the distance training and whether the steps of the surgical technique have been well followed (first ligafix check list transmitted to distributor on 10 november 2020 for test).Organisation of a meeting on february 2021 with an responsible in charge of quality system and vigilance system (ongoing).Improved our "incident report" form (regarding informations requested about the reported problem and potential patient consequences) - ongoing.·.
 
Event Description
(b)(4).Incident occured in (b)(6) - "screw was broken".Acl reconstruction / diameter of tunnel: 8mm.
 
Event Description
Fnc 2101/02136.Incident occured in vietnam - "screw was broken".Acl reconstruction / diameter of tunnel: 8mm.
 
Manufacturer Narrative
No incident during manufacturing.Waiting for recovery of the broken screw for expertise.According with the photo transmitted, the patient retain potentially a piece of the fractured screw / potential mechanical risk: risk of debris coming out of the tunnel into the joint.Very low biological risk: excess resorbable material.To complete our investigations, we requested additional information: did the surgeon indicate that the device caused or contributed to serious injury? did the patient retain piece of screw? how did the device fracture? please report on the circumstance when the event occurred.Are there any contributing factors related to the event? if yes, could you explain please? what was used to complete the procedure (part and lot information)? has the surgeon been sensitized / informed following the webinar trainings organized by sbm in 2020? if yes, before or after the date of incident? according with current legislation of your country, is this type of event should be reported to your national competent authority? no other complaint concerning this lot.Actions implemented by sbm: technical sheet with characteristics of ligafix screws was transmitted on (b)(6) 2020 to the distributor for reminder.Distance training program (impossible travels / covid19) implemented since june 20, in order to readjust the operating techniques and recall the characteristics of each product.Creating a form to check if possible, after surgery, the effectiveness of the distance training and whether the steps of the surgical technique have been well followed (first ligafix check list transmitted to distributor on (b)(6) 2020 for test).Organisation of meetings since (b)(6) 2021 with our distributor (with a responsible in charge of quality system).Improved our "incident report" form (regarding informations requested about the reported problem and potential patient consequences).Accompaniment of our distributor by our referring sales manager.Follow up 1 - device evaluation.This batch of screws presents no manufacturing defect, the batch complies with specifications.Post-injection data were very stable and the molecular weight was high which is indicative of very good manufacturing conditions.The tunnel drilled at diameter 8mm does not follow the indications given in the instructions for use, where it is requested that the drilling diameter be equal to the implant diameter: "ligafix® 60:the drilling diameter of the bone tunnel must be at least equal to that of the screw".The tip of the screw broke, at the top of the cone at the start of the recess just before the threaded part because the diameter of the tunnel drilled was ø8mm, to insert a ø9mm screw.Conclusion: the medical device was not implanted in accordance with the surgical technique, the tunnel diameter was not big enough.
 
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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
MDR Report Key11285600
MDR Text Key267518049
Report Number3004549189-2021-00002
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K070507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2022
Device Catalogue NumberCOM6009025
Device Lot Number193480
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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