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

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 06/18/2017

Event Type  Injury  

Event 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.

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.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Type of Device: 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
• MDR Text Key: 328172596
• Report Number: 1220246-2023-08747
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other