Arthrex® AR-8933L-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050068), received between Mar 5, 2019 and Oct 27, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE THREAD OF THE SCREW LOOSENED DURING INSERTION INTO THE PLATE. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022423 ↗
• InjuryAug 26, 2019Patient-Device Incompatibility

  IT HAS BEEN REPORTED THAT A PATIENT HAD UNDERGONE A PREVIOUS KNEE SURGERY USING ANOTHER MANUFACTURER¿S PRODUCT. APPROXIMATELY ONE WEEK LATER THE PATIENT THEN UNDERWENT A REVISION PROCEDURE USING AN ARTHREX PATELLA SUTUREPLATE STAR SMALL, ON (B)(6) 2019 (CASE (B)(4)). AT TIME OF SURGERY THE INTER-OPERATIVE X-RAY LOOKED GOOD. HOWEVER, ONE DAY AFTER THE SURGERY IT WAS NOTICED ON A SECOND X-RAY THAT THE FRACTURE GAP WAS OPEN AND TOO FAR APART. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE FOLLOWING IMPLANTS: AR-13059S (LOT 6045180600 - QTY1) PATELLA SUTUREPLATE STAR SMALL (NOT SOLD IN US); AR-8935L-22 (LOT W46320 - QTY 2) LOCKING SCREW; AR-8935L-20 (LOT 10224133 -QTY 3) LOCKING SCREW; AR-8935L-20 (LOT 1009169 - QTY 1) LOCKING SCREW; AR-8935L-18 (LOT 1011926 -QTY 1) LOCKING SCREW; AR-8935L-18 (LOT W584981 -QTY1) LOCKING SCREW. TO COMPLETE THE REVISION PROCEDURE THE SURGEON IMPLANTED AN ARTHREX PATELLA SUTUREPLATE II (SIZE L) WITH CORRESPONDING ARTHREX SCREWS. THE SURGEON TOOK AN X-RAY AND NOTICED THAT THE SIZE L PLATE WAS TOO BIG. SURGEON REMOVED THE PATELLA SUTUREPLATE II (SIZE L) AND SCREWS. SURGEON THEN CHANG

  Patient problems: Failure of Implant

  MAUDE report 8930502 ↗
• InjuryMar 5, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A LEFT 1ST METATARSOPHALANGEAL JOINT REVISION FUSION AND HARDWARE REMOVAL, EXTRACTION OF GRAFT AND WEIL OSTEOTOMY ON (B)(6) 2017 DUE TO PAINFUL NONUNION OF HER LEFT FIRST METATARSOPHALANGEAL JOINT FUSION. DURING THE PROCEDURE THE SURGEON EXPLANTED A PLATE AND LAG SCREWS FROM A PREVIOUS PROCEDURE (DATE OF PREVIOUS PROCEDURE AND EXPLANTED DEVICE MANUFACTURER UNKNOWN AT TIME OF INITIAL REPORT). THE SURGEON UTILIZED A 1.7 MM DRILL BIT, AR-1201-7DC, FOR MICRO DRILLING THROUGH THE FUSION SITE IN ORDER TO PROMOTE INGROWTH AND THE DRILL BIT SNAPPED OFF INTRAMEDULLARY. THE SURGEON ATTEMPTED TO REMOVE THE DRILL BIT FRAGMENT BUT WAS UNABLE TO BECAUSE OF THE LOCATION. THE OPERATIVE REPORT DATED (B)(6) 2017 NOTED THAT REMOVAL OF THE DRILL BIT FRAGMENT WOULD CAUSE MORE HARM TO THE PATIENT. THE SURGEON FINISHED THE SURGERY BY PERFORMING A CAPSULOTOMY AND WEILL OSTEOTOMY AND IMPLANTED THE FOLLOWING ARTHREX PLATE AND SCREWS: AR-8944CL-L (LOW PROFILE MTP PLATE), AR-8730-38PT (QUICKFIX SCREW), AR-8933-24 (LOW PROFILE SCREW), AR-8933-18 (LOW PROFILE SCREW), AND AR-8933L-18 (QTY 2) (LOW PROFILE LOCKING SCREW). IN (B)(6) 20

  Patient problems: Foreign Body In Patient; Necrosis; Skin Discoloration

  MAUDE report 8391614 ↗