MAUDE Adverse Event Report: ARTHREX, INC. TKL SPDBRG IMP SYS W/ BC SWVLK & NDL; BIO SOFT TISSUE FIXATN FASTNR

Model Number	TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/27/2022, it was reported by a sales representative via email that an ar-2600sbs-10 speedbridge implant system 4.75 swivelock, after being fully implanted, the locking mechanism came out when surgeon removed the inserter.This was discovered during a procedure on (b)(6) 2022.Additional information requested.
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 most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• Brand Name: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• 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: 19110694
• Report Number: 1220246-2024-02028
• Device Sequence Number: 8311942
• Product Code: MAI
• UDI-Device Identifier: 00888867369658
• UDI-Public: 00888867369658
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• 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 Model Number: TKL SPDBRG IMP SYS W/ BC SWVLK & NDL
• Device Catalogue Number: AR-2600SBS-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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