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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged swivelock from an ar-8928bc-cp was received for investigation.Visual inspection identified that the distal end of the green overmold for the swivelock inserter had ballooned out, with warping/damage also noted to the proximal end of the biocomposite anchor.The method of bone preparation employed during the procedure, as well as the bone quality encountered, were not provided.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or interference with hard/challenging bone.
Event or Problem Description
It was reported that during a speedbridge achilles tendon surgery the anchor could not be screwed in despite the thread was precut.There was no harm for patient, operator or third-party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or da a second surgery.Update swit 15-feb-2022: the anchor / the implant did not come off the driver.

• 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: 19112091
• Report Number: 1220246-2024-02034
• Device Sequence Number: 7128040
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/15/2024

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 Expiration Date: 08/31/2025
• Device Model Number: IMPL SYS,BIO-COMP ACHILLES SPEEDBRG
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 14201109
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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