MAUDE Adverse Event Report: ARTHREX, INC. SPEEDBRG IMPL SYS W/ PEEK SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SPEEDBRG IMPL SYS W/ PEEK SWVLK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2022
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.The complaint is confirmed based on the customer provided photo, which displays the anchor inserted upside down in the driver.The complaint is confirmed based on the customer provided photo, which displays the anchor inserted upside down in the driver.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On 6/28/2022, it was reported by a sales representative via email that an ar-2600sbs-6 speedbridge implant system with peek swivelock green tip of the handle split during insertion.Surgeon removed it from inside the patient and noticed the anchor was not assembled properly.This was discovered during a procedure on (b)(6) 2022.

• Brand Name: SPEEDBRG IMPL SYS W/ PEEK SWVLK
• 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: 19173533
• Report Number: 1220246-2024-02316
• Device Sequence Number: 12588770
• Product Code: MAI
• UDI-Device Identifier: 00888867160224
• UDI-Public: 00888867160224
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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 Model Number: SPEEDBRG IMPL SYS W/ PEEK SWVLK
• Device Catalogue Number: AR-2600SBS-6
• Device Lot Number: 14951936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown