MAUDE Adverse Event Report: S.B.M. SAS ECOFIX INSTRUMENTATION; ECOFIX® Ø 5.5 - 6.5 MM SCREWDRIVER

Catalog Number	EPA9000403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
03 july 2025 verification of manufacturing data: (b)(4) screwdrivers found to be compliant according tot he controls carried out.No other complaint concerning this batch number.Additional information: extract from the incident report.Preparation for repair: subacromial space cleared using shaver; pilot hole properly prepared using punch/tap per technique guide.Surgeon noted extremely dense bone.Surgeon inserted anchor slowly due to dense bone taking care to not place additional torque on the anchor during insertion.Upon removal of the inserter, tip of the metallic inserter was found broken off and lodged within the central cannulation of the anchor.Fragment was fully contained and not proud.Surgeon opted not to remove anchor to avoid escalation to open surgery and further bone damage.Remaining repair proceeded normally with lateral knotless 4.5mm ecofix anchor for suture tape.No additional soft tissue repair required.Anchor integrity maintained despite inserter breakage.Investigations in progress - we are waiting for the screwdriver to be recovered for analysis.____________________________________________________.
Event or Problem Description
(b)(4).Incident occured in usa.Description of incident: instrument breakage - metallic inserter tip broke off inside anchor: upon removal of the inserter, tip of the metallic inserter was found broken off and lodged within the central cannulation of the anchor.
Event or Problem Description
(b)(4).Incident occured in usa.Description of incident: instrument breakage - metallic inserter tip broke off inside anchor: upon removal of the inserter, tip of the metallic inserter was found broken off and lodged within the central cannulation of the anchor.
Additional Manufacturer Narrative
03 july 2025.Verification of manufacturing data: 41 screwdrivers found to be compliant according to the controls carried out.No other complaint concerning this batch number.Additional information: extract from the incident report.Preparation for repair: subacromial space cleared using shaver; pilot hole properly prepared using punch/tap per technique guide.Surgeon noted extremely dense bone.Surgeon inserted anchor slowly due to dense bone taking care to not place additional torque on the anchor during insertion.Upon removal of the inserter, tip of the metallic inserter was found broken off and lodged within the central cannulation of the anchor.Fragment was fully contained and not proud.Surgeon opted not to remove anchor to avoid escalation to open surgery and further bone damage.Remaining repair proceeded normally with lateral knotless 4.5mm ecofix anchor for suture tape.No additional soft tissue repair required.Anchor integrity maintained despite inserter breakage.Investigations in progress - we are waiting for the screwdriver to be recovered for analysis.03 march 2026 - follow up1.Result of expertise.Manufacturing data verification: the lot complies with the expected specifications.Bone quality qualified as extremely dense.Very dense bone increases the insertion torque that can damage the anchor and/or the screwdriver.Defective screwdriver: the groove width of the damaged screwdriver is compliant.A hardness test was performed (critt report n°25-11-055) to verify compliance with the expected specification (greater than or equal to 47 hrc).The measured value confirmed the hardness reported by the rod supplier (tth bodycote certificate n°310r.17147).Break test on a screwdriver from the same batch: the results obtained show that the ecofix ø 5.5-6.5 mm screwdriver ref.Epa9000403 has greater torsional resistance than the anchors.Under normal use, with the anchor correctly positioned on the screwdriver and inserted at the same angle as the pilot hole, this tool should not fail.The failure was not reproduced during these tests.Hypotesis: the failure encountered is possibly due to incorrect positioning of the anchor on the screwdriver shaft or incorrect insertion into the bone at an angle different from that of the pilot hole.Note: in october 2025, a note was added to the surgical technique brochure (ref.Brtop-mk-techop-ecofix-en-001_a english version - ref bptop-mk-techop-ecofix-fr-001_a french version), in the pre-drilling phase on pages 2, 4, and 6, for cases where the bone is dense: "when the bone is dense, drill several times in succession to form the pre-hole properly." this latest version of the brochure was sent to the distributor along with the results of the investigations in the closing email.Risk management report of ecofix: update of document rmr 2019.03.2 ecofix, with the inclusion of the risk of screwdriver breakage (risk ur-16 to be completed or creation of a new risk).Revision and/or development of the description of possible risks for this type of incident.

• Brand Name: ECOFIX INSTRUMENTATION
• Common Device Name: ECOFIX® Ø 5.5 - 6.5 MM SCREWDRIVER
• 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: 22392666
• Report Number: 3004549189-2025-00011
• Device Sequence Number: 9401229
• Product Code: HXX
• UDI-Device Identifier: 03760304681127
• UDI-Public: 03760304681127
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: EPA9000403
• Device Lot Number: 233242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male