PNCH, WB XL, 2.75 W/FLUSHPORT
Received Dec 8, 2025 · Event occurred Nov 18, 2025
Report 1220246-2025-05484 · MDR key 23744166
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
PNCH, WB XL, 2.75 W/FLUSHPORTCatalog number
AR-11040XLF
Lot number
15472327
Product problems
- Failure to Cut
- Detachment of Device or Device Component
- Failure to Cut
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE RIVET FROM THE MECHANISM FELL OFF AND THEREFORE THE DEVICE DOES NOT CUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED AR-11040XLF WITH BATCH 15472327 NOTED THAT THE TIP PIN IS MISSING (SEE EVALUATION PICTURES 2 + 3). A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE. FURTHER, THE SHAFT IS SLIGHTLY BENT (SEE EVALUATION PICTURE 1).
Description of Event or Problem
UPDATE DW 11-DEC-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED ISSUE WAS IDENTIFIED PRIOR TO USE ON THE PATIENT. THE SURGERY WAS LATER FINISHED SUCCESSFULLY BUT NO FURTHER INFORMATION WAS PROVIDED HOW THE PROCEDURE WAS THEN PERFORMED.