SUTURE CUTTER, OPEN ENDED, LEFT NOTCH
Received Apr 20, 2026 · Event occurred Mar 23, 2026
Report 1220246-2026-02305 · MDR key 24929334
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
SUTURE CUTTER, OPEN ENDED, LEFT NOTCHCatalog number
AR-11794L
Lot number
10252536
Product problems
- Positioning Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 1ST APRIL 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA AN EMAIL THAT FOR 1 UNIT OF AR-11794L, SUTURE CUTTER, OPEN ENDED LEFT NOTCH, Ø 4.2 MM, IT WAS UNABLE TO CUT AS THE PIN HAS COME LOOSE. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A DIFFERENT SUTURING TECHNIQUE. SINCE THE PROCEDURE WAS NEARING COMPLETION, THERE WAS NO COMPLICATION AND NO PATIENT HARM.