Arthrex® AR-8933L-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050105), received between Jan 23, 2018 and Aug 26, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• InjuryAug 26, 2019Positioning Problem

  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 CHAN

  Patient problems: Failure of Implant

  MAUDE report 8930452 ↗
• InjuryJan 23, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HIS RIGHT FOOT ON (B)(6) 2017 WHERE A 4 MM PROXIMAL WEDGE PLATE ((B)(4)) AND A 3.5 MM HEADLESS SCREW FOR CHEVRON ((B)(4)) WERE IMPLANTED. ALSO IMPLANTED WAS A 2.4 HEADED SCREW FOR K-WIRE BUT REPORTER DOES NOT BELIEVE THIS IS AN ARTHREX PRODUCT. THE PATIENT BEGAN TO EXPERIENCE HEAT AND SWELLING IN HIS FOOT ABOUT 2 MONTHS POST-OP. THE SURGEON IS CONSIDERING REMOVING THE HARDWARE. PATIENT'S ONLY KNOWN DRUG ALLERGY IS TO NEOMYCIN ANTIBIOTIC OINTMENT. FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017, PATIENT IS A MALE, SURGERY WAS ON RIGHT FOOT. PATIENT HAS SIGNIFICANT SWELLING TO DATE, 4.5 MONTHS AFTER SURGERY. DECISION TO REMOVE THE HARDWARE HAS NOT BEEN MADE. PATIENT IS STILL EXPERIENCING THE LOCALIZED HEAT AND SWELLING AT THE SURGICAL SITE. PART NUMBERS HAVE NOW BEEN OBTAINED AND THE MATERIAL COMPOSITION OF EACH IMPLANT HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Swelling

  MAUDE report 7211699 ↗
• InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HIS RIGHT FOOT ON (B)(6) 2017 WHERE A 4MM PROXIMAL WEDGE PLATE (LINE: 207434) AND A 3.5MM HEADLESS SCREW FOR CHEVRON (LINE: 207435) WERE IMPLANTED. ALSO IMPLANTED WAS A 2.4 HEADED SCREW FOR K-WIRE BUT REPORTER DOES NOT BELIEVE THIS IS AN ARTHREX PRODUCT. THE PATIENT BEGAN TO EXPERIENCE HEAT AND SWELLING IN HIS FOOT ABOUT 2 MONTHS POST-OP. THE SURGEON IS CONSIDERING REMOVING THE HARDWARE. PATIENT'S ONLY KNOWN DRUG ALLERGY IS TO NEOMYCIN ANTIBIOTIC OINTMENT. FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017, PATIENT IS A MALE, SURGERY WAS ON RIGHT FOOT. PATIENT HAS SIGNIFICANT SWELLING TO DATE, 4.5 MONTHS AFTER SURGERY. DECISION TO REMOVE THE HARDWARE HAS NOT BEEN MADE. PATIENT IS STILL EXPERIENCING THE LOCALIZED HEAT AND SWELLING AT THE SURGICAL SITE. PART NUMBERS HAVE NOW BEEN OBTAINED AND THE MATERIAL COMPOSITION OF EACH IMPLANT HAS BEEN PROVIDED.

  Patient problems: No Code Available; Swelling

  MAUDE report 7211696 ↗