MAUDE Adverse Event Report: S.B.M. SAS RIGIDLOOP; RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM - XL

Catalog Number	232485
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Fnconf-24-0145 incident occured in usa.Event description: "white loop sutures on btb button snapped in half while pulling graft into femoral tunnel".Additional information: was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 90 , action taken when event occurred? --> new implant opened, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, device property of -->none, device in possession of -->none.
Additional Manufacturer Narrative
13 august 2024 no patient consequence - no signs, symptoms or patient involvement.There was a delay in surgery of 90mn.Additional information requested to complete our investigation.The 2 products are not available for expertise - discarded.Insufficient information / analysis is ongoing.Note: a paper medwatch 3500 form was mailed by the quality manager under reference fnconf-24-0145.The e submitter version cancels and replaces this document.____________________________________________________.
Additional Manufacturer Narrative
(b)(6) 2024.No patient consequence - no signs, symptoms or patient involvement.There was a delay in surgery of 90mn.Additional information requested to complete our investigation.The 2 products are not available for expertise - discarded.Insufficient information / analysis is ongoing.Note: a paper medwatch 3500 form was mailed by the quality manager under reference fnconf-24-0145.The esubmitter version cancels and replaces this document.(b)(6) 2025.Additional information: was surgery delayed due to the reported event? yes if yes, number of minutes: 90 action taken when event occurred? new implant opened, was procedure successfully completed? yes were fragments generated? no if yes, were they removed easily without additional intervention? unknown patient status/ outcome / consequences no was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc revision) required: unknown is the patient part of a clinical study: unknown result of expertise / event analysis: batch 240467 complies with production requirements.Result of investigation: the tensile strength of the white braid loops is > 650 n.The tensile strength of a single strand is > 400 n.These force levels cannot be applied manually.The tensile force exerted on the white braid strands when tensioning the rigidloop btb device is < 100 n.The rupture of the white braid loops could therefore only have been caused by interference between the white braid loops and a sharp edge, which caused the white braid fibers to be cut.The absence of the defective device and photographs make it impossible to determine the location of the ruptured areas.The graft is placed in the femur as follows (excerpt from surgical technique 14854-mitek rigidloop btb surgical technique guide r12): use the relay suture to pull the rigidloop¿ btb adjustable cortical system sutures through the femoral socket.Pull the rigidloop¿ btb adjustable cortical system into the joint space.Pull lightly on the blue/white suture to position the button near the entrance of the femoral socket.Use the blue/white suture to pull the button through the socket, and lightly pull other sutures, as needed, to avoid tangles.The white braid strands are therefore not subjected to traction during passage of the device into the femur.The only interference the white braid loops have with a wall that could cause damage to the braid occurs during insertion of the bone rod into the femoral tunnel.At this stage, the braid strands, positioned on either side of the bone rod, come into contact with the cortical edge of the tunnel entrance opening.This edge is hard, sharp, and prominent.If the clearance between the tunnel diameter and the size of the graft bone block is insufficient, then the rigidloop's white braid loops come into conflict with the cortical edge of the tunnel when the device is pulled, potentially causing damage to the fibers if a significant tensile force is applied.The insistence of pulling the device into the tunnel can cause the white braid loops to break.Potential root cause: insufficient functional clearance between tunnel and bone graft: the diameter of the tunnel was not drilled large enough following the calibration of the bone block of the graft.The root cause is not clearly identified (device was scrapped / no photos) - no action implemented.
Event or Problem Description
(b)(4).Incident occured in usa.Event description: "white loop sutures on btb button snapped in half while pulling graft into femoral tunnel".Additional information: was surgery delayed due to the reported event? yes, if yes, number of minutes: 90, action taken when event occurred? --> new implant opened, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, device property of: none, device in possession of: none.

• Brand Name: RIGIDLOOP
• Common Device Name: RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM - XL
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer Contact: regine estaun ; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 19982333
• Report Number: 3004549189-2024-00004
• Device Sequence Number: 20868328
• Product Code: MBI
• UDI-Device Identifier: 03760304680212
• UDI-Public: 03760304680212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 232485
• Device Lot Number: 240467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown