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

Model Number	IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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
On 11/11/2025, a sales representative reported via email that the anchor of the swivelock from the ar-8929bc-cp achilles mid substance speedbridge implant system, snapped during insertion.The bone was prepared, drilled, and tapped according to the recommended technique.The eyelet remained in place with a partial anchor because the portion already inserted could not be removed.This was discovered during an achilles repair procedure on (b)(6) 2025.Additional information was received on 11/17/2025: the surgeon reported that the anchor of the swivelock from the ar-8929bc-cp achilles mid-substance speedbridge implant system felt normal resistance upon insertion.The anchor was partially inserted when it broke.No additional products were used to complete the case because the anchor remained secure with partial insertion.There was a case delay of approximately 3¿5 minutes, resulting in an additional 3¿5 minutes of anesthesia.All detached fragments were accounted for and retrieved.The eyelet remained intact during the event.Bone preparation for implant insertion was performed using the instrumentation provided in the kit.The drill, drill guide, and hand tap were used; the power tap was not used.The bone was assessed as hard but not abnormally hard.No adverse effects have been reported.No photos were taken of the event.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is improper bone preparation, as the anchor appears to have been implanted into hard, dense bone.Dfu-0309-eo revision 3 speedbridge¿ and suturebridge¿ implant systems attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• 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: 23684846
• Report Number: 1220246-2025-05291
• Device Sequence Number: 15891320
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: (01)00888867131651(11)250625(17)290531(10)15456316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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 Model Number: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• Device Catalogue Number: AR-8929BC-CP
• Device Lot Number: 15456316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown