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

Catalog Number 232485

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

No incident during manufacturing - no other complaint concerning this batch number.The device is discarded - not available for expertise.Additional information requested by sbm / received on 03 may 2022: is it possible to have the batch number of this device? code 232485 lot 216188.The local description of the event stipulates that there was no damage to the patient being a cadaver ligament: did this event occur during a clinical test on a cadaver? the ligament used for the reconstruction of the cruciate was from the tissue bank and therefore it was a donor ligament to be corpse: from the same anatomical piece it was possible to take a second ligament for the reconstruction on the patient.Did the health care facility declare this incident to the national competent authority? no.Further questions to our distributor to complete our investigation: were there any contributing conditions related to the event? (trauma, illness, previous surgery, patient anatomy.) how did the bone fracture? please report on the circumstance and use when the event occurred.Device implantation area: particular bone quality? diameter of transplant? has a prior tapping of the tunnel been carried out? what is the patient's condition today? did the surgeon indicate that the device malfunctioned or failed to perform as intended? insufficient information / analysis is ongoing.____________________________________________________.

Event Description

(b)(4).Incident occured in (b)(6): information transmitted by our distributor: event date was april 15th for one product code 232485 rigidloop bone-tendon-bone (btb) adjustable button with unknown lot number.This device is not available to return to manufacturer.Event description: "the bone is broken during ligament traction".Was surgery delayed due to the reported event? yes, if yes, number of minutes: 90, action taken when event occurred? use of a different device , 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.No signs, symptoms or patient involvement.Surgery prolonged.

Manufacturer Narrative

No incident during manufacturing - no other complaint concerning this batch number.The device is discaded - not available for expertise.Additional information requested by sbm / received on 03 may 2022: is it possible to have the batch number of this device? code 232485, lot 216188.The local description of the event stipulates that there was no damage to the patient being a cadaver ligament: did this event occur during a clinical test on a cadaver? the ligament used for the reconstruction of the cruciate was from the tissue bank and therefore it was a donor ligament to be corpse: from the same anatomical piece it was possible to take a second ligament for the reconstruction on the patient.Did the health care facility declare this incident to the national competent authority? no.Further questions to our distributor to complete our investigation: were there any contributing conditions related to the event? (trauma, illness, previous surgery, patient anatomy.) how did the bone fracture? please report on the circumstance and use when the event occurred.Device implantation area: particular bone quality? diameter of transplant? has a prior tapping of the tunnel been carried out? what is the patient's condition today? did the surgeon indicate that the device malfunctioned or failed to perform as intended? insufficient information / analysis is ongoing.Follow up1 - (b)(6) 2022.This is a revision surgery following a failure of a first intervention with competitor products.There was a particularity: the ligament used for the reconstruction of the cruciate was from the tissue bank and therefore it was a donor ligament to be corpse.Bone broke in the proximal part where the device is fixed to the femoral fixation device adjustable btb and it broke during the traction phase of the ligament in the femoral tunnel, the implant was not returned - it was discarded.No photos.This analysis is based on manufacturing data and data provided by user and distributor.The components making up the medical device comply with our specifications and the system has been properly assembled - hypothesis: the bone block fractured because the hole through which the braids of the rigidloop must pass was drilled too close to the edges which made the bone block fragile.No corrective action implemented.

Event Description

(b)(4).Incident occured in italy: information transmitted by our distributor: event date was april 15th for one product code 232485 rigidloop bone-tendon-bone (btb) adjustable button with unknown lot number.This device is not available to return to manufacturer.Event description: "the bone is broken during ligament traction".Was surgery delayed due to the reported event? yes, if yes, number of minutes: 90, action taken when event occurred? use of a different device , 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.No signs, symptoms or patient involvement.Surgery prolonged.

• Brand Name: RIGIDLOOP
• Type of Device: RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM - STANDARD
• 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 bareilles ; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 14305488
• MDR Text Key: 290937919
• Report Number: 3004549189-2022-00002
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 232485
• Device Lot Number: 216188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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