Arthrex® AR-18716V-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867313668), received between Sep 21, 2020 and Dec 21, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RIGHT HAND ORIF OF 4TH AND 5TH METACARPAL FRACTURES PROCEDURE THE SURGEON WAS USING THE ARTHREX MINI COMPREHENSIVE FIXATION SYSTEM AR-18700FS. WHEN SURGEON WAS REDUCING THE 4TH METACARPAL FX THE POINT-TO-POINT CLAMP TIPS ON THE AR-18700-45 BENT. ANOTHER ISSUE OCCURRED WHEN HE WAS PLATING THE 5TH METACARPAL LATER IN THE CASE. HE WAS USING THE DEPTH GAUGE AR-18700-27 (FROM THE AR-18700FS) TO MEASURE THE LENGTH OF THE SCREW AND THE DEPTH GAUGE PIN ASSEMBLY BENT IN MULTIPLE DIRECTIONS. THERE WAS ANOTHER ISSUE WITH TWO OF THE VAL 1.6MM SCREWS THAT WERE PLACED IN THE PLATE LOCATED ON THE 5TH METACARPAL. WHEN ADVANCING A 1.6 X 09MM SCREW, AR-18716V-09, THE SCREW HEAD SNAP OFF THE SCREW BEFORE THE THREADS OF THE LOCKING HAD EVER ENGAGED WITH THE PLATE. THIS HAPPENED IN THE EXACT SAME WAY WITH A 1.6 X 10MM SCREW, AR-18716V-10. THE SCREW THREADS THAT HAD MADE IT THROUGH THE PLATE AND THAT WERE ADVANCED INTO THE BONE WERE LEFT IN THE PATIENT'S BONE. ADDITIONAL INFORMATION OBTAINED 11/30/2020: THE AR-18700-45 AND AR-18700-27 WERE FROM THE AR-18700FS INSTRUMENT SET. THE TWO INSTRUMENTS WILL BE RETURNED FOR EVALUATION. THE PROXIMAL ENDS OF THE AR-18716V-09 AND AR-18

  Patient problems: Failure of Implant

  MAUDE report 11046323 ↗
• InjurySep 21, 2020Failure to Align; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN (B)(6) 2020 METACARPAL FX PROCEDURE THE SURGEON WAS USING AN AR-18716V-09 SCREW WHICH DID NOT WANT TO LOCK INTO THE AR-18716P-03 PLATE (LOT 04521913). THE SURGEON USED ANOTHER ONE AND IT FINALLY LOCKED INTO THE PLATE AND THE CASE WAS FINISHED. TO PREP THE BONE THE SURGEON HAD USED THE 1.2MM RECOMMENDED DRILL. THE LOT NUMBER IS UNKNOWN BECAUSE THE SCREW WAS FROM THE DISTRIBUTOR'S MINI CFS TRAY (#2) AND SCREW LOTS ARE NOT RECORDED IN THE TRAY. APPROXIMATELY A WEEK LATER THE SURGEON THE SURGEON REPORTED TO THE SALES REPRESENTATIVE THAT THE SURGEON HAD TO REVISION THAT FRACTURE AGAIN BECAUSE THAT SAME LOCKING SCREW BACKED OUT. THE REVISION PROCEDURE TOOK PLACE (B)(6) 2020 AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION THE AR-18716V-09 SCREW WAS EXPLANTED AND A REPLACEMENT SCREW OF THE SAME SIZE WAS IMPLANTED. DEVICE WILL NOT BE RETURNED AS THE DEVICE WAS DISCARDED BY THE SURGEON DURING THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 10563428 ↗