MAUDE Adverse Event Report: S.B.M. SAS ECOFIX; ECOFIX®+ Ø 5.5 MM THREADED TRIPLE-LOADED SUTURE ANCHOR SYSTEM

Catalog Number	EPAV455CLA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
February 26, 2026.Verification of manufacturing data: the batch complies with expected specifications.No clinical consequences to the patient - no additional surgery - the patient retains a piece of the defective device - delay in surgery over than 30mn (stipulated in the incident report).Additional information: the bone canal was opened in advance using the original sbm brand initiator.When inserting the 5.5 mm ecofix anchor, unusual resistance accompanied by an abnormal noise (cracking) was perceived, indicating that the device was penetrating forcibly despite the prior preparation of the tunnel.Once approximately half of the implant had been inserted, arthroscopy revealed that the anchor body had ruptured.In response to this structural failure of the device, appropriate corrective measures were taken during the surgical procedure to preserve the patient's integrity.Questions asked: did the surgeon make a pre-hole? yes.Particular bone quality? good.The incident report indicates that the patient retained pieces of the anchor: can pieces migrate? yes.If yes, what might the consequences be? none, because they are extraosseous.The incident report indicates that the operating time was increased by more than 30 mn as a result of this incident: can you confirm this point? 30mn.What is the reason for this 30mn delay? to try to recover the broken pieces? other? unusual resistance was encountered and a brief maneuver was performed to remove the remaining fragments, and another anchor was put in place.What was used to complete the procedure (the same lot number / other)? the same lot.We are waiting to recover the device as far as possible for an assessment.____________________________________________________.
Event or Problem Description
(b)(4).Incident occured in venezuela.Complaint description: "broken anchor, at the moment of the anchor insertion on the tunnel".
Event or Problem Description
Fnconf-(b)(4) incident occured in venezuela.Complaint description: "broken anchor, at the moment of the anchor insertion on the tunnel".
Additional Manufacturer Narrative
February 26, 2026 verification of manufacturing data: the batch complies with expected specifications.No clinical consequences to the patient - no additional surgery - the patient retains a piece of the defective device - delay in surgery over than 30mn (stipulated in the incident report).Additional information: the bone canal was opened in advance using the original sbm brand initiator.When inserting the 5.5 mm ecofix anchor, unusual resistance accompanied by an abnormal noise (cracking) was perceived, indicating that the device was penetrating forcibly despite the prior preparation of the tunnel.Once approximately half of the implant had been inserted, arthroscopy revealed that the anchor body had ruptured.In response to this structural failure of the device, appropriate corrective measures were taken during the surgical procedure to preserve the patient's integrity.Questions asked: did the surgeon make a pre-hole? yes particular bone quality? good the incident report indicates that the patient retained pieces of the anchor: can piece.S migrate? yes if yes, what might the consequences be? none, because they are extraosseous.The incident report indicates that the operating time was increased by more than 30 mn as a result of this incident: can you confirm this point? 30mn what is the reason for this 30mn delay? to try to recover the broken pieces? other? unusual resistance was encountered and a brief maneuver was performed to remove the remaining fragments, and another anchor was put in place.What was used to complete the procedure (the same lot number / other)? the same lot.We are waiting to recover the device as far as possible for an assessment.May 27, 2026 result of analysis - follow up1.No incidents occurred during production - no scrap.The batch conforms to expected specifications.Analysis of the incident: it is indicated that the bone quality was good and it is also indicated that an unusual resistance was perceived.It is possible to think that the bone was hard.In the video, the anchor seems to not advance and a breakage of the anchor's nose is visible at the end.The information collected does not clearly identify the cause of the incident.Conclusion: the failure seems to be due to excessive force being applied during insertion.Identified potential causes: incorrect pilot-hole diameter; insufficient pressure on the driver to advance the anchor during screwing and/or very/too high bone density (in dense bone, it is recommended to tap several times successively to properly shape the pilot-hole).Note: different anchor diameters are designed for different bone densities.Using an anchor diameter that is not appropriate for the bone density can lead to failure.The surgical procedure guidelines for this product family (fixit, compositcp, and ecofix) specify this.These new versions are currently being finalized and validated.The sbm sales department will send the updated documentation.

• Brand Name: ECOFIX
• Common Device Name: ECOFIX®+ Ø 5.5 MM THREADED TRIPLE-LOADED SUTURE ANCHOR SYSTEM
• 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: 24452720
• Report Number: 3004549189-2026-00005
• Device Sequence Number: 21369362
• Product Code: MAI
• UDI-Device Identifier: 03760304680656
• UDI-Public: 03760304680656
• Combination Product (Y/N): N
• Initial Reporter Country: VE
• PMA/510(K) Number: K231787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: EPAV455CLA
• Device Lot Number: 253699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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