MAUDE Adverse Event Report: SURGICAL FUSION TECHNOLOGIS GMBH SF PUSH-IN ANCHOR 2.3

Model Number	SF PUSH-IN ANCHOR 2.3
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, surgical fusion technologies gmbh (sft) was notified by a u.S.Sales representative of a fixation failure, potentially involving the sf push-in anchor 2.3 implanted in an orthopedic soft-tissue fixation procedure.The reconstruction had reportedly become loose, as observed during clinical follow-up.At the time of the report, it was unclear whether the failure was attributable to the sft implant or the suture material, which was not supplied by sft.On (b)(6) 2025, the treating surgeon performed a revision surgery and confirmed intraoperatively that the sf push-in anchor 2.3 had dislodged from its original position.The explanted device was not retained and is therefore unavailable for return or analysis by the manufacturer.The surgeon noted that a suture tape (non-sft product) had been used in conjunction with the sf push-in anchor 2.3.As stated in the sft instructions for use (ifu) and the surgical technique, use of suture tape with this implant size is not indicated.Following the explanation of the sft device, a larger third-party anchor was implanted.This device also became dislodged post-operatively, as reported to sft on (b)(6) 2025.The surgeon attributed both implant failures to weak bone.Based on the clinical feedback and the absence of the returned device, sft was unable to conduct a product-specific root cause analysis.Based on our review of all currently available information, sft has no reason to suspect that the product failed to meet any specifications at the time of manufacture.
Event or Problem Description
A patient previously implanted with the sf push-in anchor 2.3 underwent a revision procedure on (b)(6) 2025 due to suspected fixation failure.Intraoperative findings indicated that the anchor had become dislodged.A larger, third-party implant was used to replace the original anchor.Subsequently, on (b)(6) 2025, surgical fusion technologies was notified that the replacement device also failed due to dislodgement.No adverse patient outcome beyond reoperation was reported.

• Brand Name: SF PUSH-IN ANCHOR 2.3
• Common Device Name: SF PUSH-IN ANCHOR 2.3
• Manufacturer (Section D): SURGICAL FUSION TECHNOLOGIS GMBH; wagistrasse 6; schlieren, zurich 8952 ; SZ 8952
• Manufacturer (Section G): SURGICAL FUSION TECHNOLOGIES GMBH; wagistrasse 6; schlieren, zurich 8952 ; SZ 8952
• Manufacturer Contact: johannes frueh ; wagistrasse 6; schlieren, zurich 8952 ; SZ 8952
• MDR Report Key: 22608099
• Report Number: 3022518322-2025-00001
• Device Sequence Number: 9737485
• Product Code: MAI
• UDI-Device Identifier: 07649990202167
• UDI-Public: 07649990202167
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K240288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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 Model Number: SF PUSH-IN ANCHOR 2.3
• Device Catalogue Number: B04-401
• Device Lot Number: 22-0032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 08/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FIXATION FAILURE; ORIGINAL SURGERY.; REVISION SURGERY, THIRD-PARTY DEVICE INSERTED.; THIRD-PARTY DEVICE FAILED DUE TO DISLODGEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown