QUAD TENDON STRIPPER- CUTTER
Received Dec 29, 2025 · Event occurred Dec 8, 2025
Report 1220246-2025-05856 · MDR key 23906608
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
QUAD TENDON STRIPPER- CUTTERCatalog number
AR-2384
Product problems
- Dull, Blunt
- Dull, Blunt
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE. THE DEVICE'S MANUFACTURING DATE IS 26-FEB-2021.
Description of Event or Problem
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2384, QUAD TENDON STRIPPER-CUTTER, WAS BLUNT. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE CUTTER STILL WORKED BUT WAS BLUNT AND WAS HARD TO USE.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.