Arthrex® AR-8933L-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050082), received between Aug 26, 2019 and Aug 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device-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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2019Device-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: No Known Impact Or Consequence To Patient

  MAUDE report 8930478 ↗
• InjuryAug 26, 2019Device-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: No Known Impact Or Consequence To Patient

  MAUDE report 8930467 ↗