MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES SPEEDBRG; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an hamstring surgery the swivelock anchor broke during insertion into the bone.No parts remained in the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8928bc-cp batch 15294339 was received for evaluation.Visual inspection revealed that the screw was broken; only a fragment was returned for evaluation.Upon examining the returned piece, it was noted that the threads were warped, indicating that excessive force had been applied.Similar damage was also observed on the tip of the outer molded shaft.Functional testing evaluated how the inner shaft and the outer shaft function together; no issues or resistance were found.The most likely cause of the reported and observed failure is user error, specifically, improper bone preparation, misalignment during insertion, and/or leveraging the device while inserting it.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22098487
• Report Number: 1220246-2025-02266
• Device Sequence Number: 20675794
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: (01)00888867049123(11)240729(17)280630(10)15294339
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 15294339
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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
• Patient Sex: Unknown