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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 it was reported by an arthrex subsidiary employee via email that an ar-8928bc-cp biocomposite achilles speedbridge implant delivery was used during an achilles tendon repair procedure on (b)(6) 2017.After the surgery, the patient complained of pain due to the protrusion of the anchor.A revision surgery was performed to remove the anchor on (b)(6) 2017.The patient recovered well after the revision surgery.No further information has been reported.Additional information received on (b)(6) 2023: this information was obtained from case data included in a summary of an academic conference presentation.Per the arthrex subsidiary employee, the sales representative does not know the exact date of the revision surgery, but it is estimated to be on (b)(6) 2017.No further information could be obtained regarding this these surgeries.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is patient specific event, specifically, an allergic reaction to the implanted device.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18140389
• Report Number: 1220246-2023-08747
• Device Sequence Number: 12773931
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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