FDA Adverse Event Malfunction Summary report: N

UNK

MDR report key: 24410794 · Received February 22, 2026

Report

Report Number
1220246-2026-00776
Event Type
Malfunction
Date Received
February 22, 2026
Date of Event
October 1, 2024
Report Date
February 22, 2026
Manufacturer
ARTHREX, INC.
Product Code
HWC
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
501

Narratives

Description of Event or Problem · 0

ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON OCTOBER 2024 BY THE ASIA PAC J SPORTS MED ARTHROSC REHABIL TECHNOL ¿RETROSPECTIVE COHORT STUDY COMPARING POSTOPERATIVE JOINT STABILITY BETWEEN ALL-INSIDE PCL RECONSTRUCTION TECHNIQUE AND CONVENTIONAL PCL RECONSTRUCTION TECHNIQUE IN PATIENTS WITH MULTILIGAMENT KNEE INJURY.¿ THE STUDY REVIEWED 20 PATIENTS IDENTIFIED ACL/PCL INSTABILITY WITH THE BIOABSORBABLE INTERFERENCE SCREWS AND TENODESIS SCREW THAT RESULTED IN PROMINENT SCREW POSITIONING IN 1 PATIENT DURING THE 8-YEAR FOLLOW-UP. REF: BURANAPUNTARUK T, BOONCHALIAW N, ITTHIPANICHPONG T. RETROSPECTIVE COHORT STUDY COMPARING POSTOPERATIVE JOINT STABILITY BETWEEN ALL- INSIDE PCL RECONSTRUCTION TECHNIQUE AND CONVENTIONAL PCL RECONSTRUCTION TECHNIQUE IN PATIENTS WITH MULTILIGAMENT KNEE INJURY. ASIA PAC J SPORTS MED ARTHROSC REHABIL TECHNOL. OCT 2024; 38:9-13. DOI: 10.1016/J.ASMART.2024.07.001.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
471932 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown