MAUDE Adverse Event Report: S.B.M. SAS PULLUP; PULLUP ADJUSTABLE JUXTACORTICAL FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION

Catalog Number PULLU01201

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  Injury  

Event Description

(b)(4).Incident occured in (b)(6): description of the incident: "two white wires used for tightening, go into the same hole"."when the surgeon knew the problem, it already squeezed 1 end, can't take it out anymore".Clinical consequence: "not yet".Additional surgery: "not yet".Patient retains a piece of the first medical device used.Surgical time was increased over than 30 mn related to this event.

Manufacturer Narrative

Date: (b)(6) 2022.No incident during manufacturing - no other complaint concerning this batch number.Additional information: the first pullup had a defect (description of the incident) and a second was used to complete the surgery: is it correct? i confirmed that just 1 pullup had a defect.Was the surgical technique strictly followed? yes.Did this delay over than 30mn involve the revision of the anesthesia protocol? no.Is the surgeon familiar with the medical device? yes.According with current legislation of your country, is this type of event should be reported to your national competent authority? no.A photo is available for assessment and we are waiting for further information: analysis is ongoing.

Manufacturer Narrative

Date: june 20, 2022.No incident during manufacturing - no other complaint concerning this batch number.Additional information: the first pullup had a defect (description of the incident) and a second was used to complete the surgery: is it correct? i confirmed that just 1 pullup had a defect.Was the surgical technique strictly followed? yes did this delay over than 30mn involve the revision of the anesthesia protocol? no is the surgeon familiar with the medical device? yes according with current legislation of your country, is this type of event should be reported to your national competent authority? no a photo is available for assessment and we are waiting for further information: analysis is ongoing.____________________________________________________ date: october 18, 2022 - follow up1 - additional information.The patient kept a piece of the first device used - surgical time was increased over than 30mn related to this event.The manufacturing data does not reveal any production anomalies.The manufactured devices comply with the manufacturing data.No anomalies and/or scrap during the assembly phase.The presence of the two free strands of the white braid in the same hole is due to the fact that the braid moved in the plate and more particularly that the strand migrated from the exit end of the 2nd splice into the passage hole of the braid strand of the 1st splice.Verification: passage of the strand of the 2nd splice into the passage hole of the 1st one requires a tensile force on the braid while maintaining the plate.When this phenomenon occurs, a hard point can be felt.Passing the device through the tunnel according to our recommendations for use cannot cause this phenomenon.Tensioning the device by alternately pulling the two strands of the white braid according to our recommendations for use cannot cause this phenomenon.The only test configuration where this phenomenon could be reproduced is when removing the device from the assembly card.The phenomenon has been reproduced with the button-plate positioned inside the flap of the assembly card where the notch is and when pulling the braid from one side of the loop.Hypothesis n°1: when removing pullup from the assembly card, the strand under the button-plate must have been dragged.Hypothesis n° 2: the medical device was damaged before assembly, it should not have been assembled, and should have been replaced by another one.Event very isolated - expertise report transmitted to our distributor for explanation - technical support provided by our sales department.No corrective action implemented.

Event Description

Fnconf-22-0090.Incident occured in vietnam: description of the incident: "two white wires used for tightening, go into the same hole" - "when the surgeon knew the problem, it already squeezed 1 end, can't take it out anymore".Clinical consequence: "not yet".Additional surgery: "not yet".Patient retains a piece of the first medical device used - surgical time was increased over than 30 mn related to this event.

• Brand Name: PULLUP
• Type of Device: PULLUP ADJUSTABLE JUXTACORTICAL FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION
• 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: 14743172
• MDR Text Key: 295028843
• Report Number: 3004549189-2022-00004
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K151004
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PULLU01201
• Device Lot Number: 215501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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