NA 309.501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982185778), received between Jan 31, 2017 and Apr 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 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.

• MalfunctionApr 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW DRIVERS WERE STRIPPED. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1)CONICAL EXTRACTION DEVICE FOR THRD WASHERS. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807314 ↗
• MalfunctionAug 13, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE EXTRACTION SCREW IS BENT OUT OF SHAPE. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES ARE UNKNOWN AND UNKNOWN IF OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION WAS REQUIRED). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8889270 ↗
• MalfunctionJan 31, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROSCOPY PROCEDURE ON (B)(6) 2017 FOR THE ATTEMPTED HARDWARE REMOVAL OF A SYNTHES LOCKING LATERAL PROXIMAL TIBIAL PLATE AND SIX (6)LOCKING SCREWS. IT WAS REPORTED THAT THE DEVICES WERE TOO CLOSE TO THE PATIENT¿S SKIN AND WERE BOTHERING HIM. THE ORIGINAL SURGERY WAS PERFORMED APPROXIMATELY TEN (10) YEARS AGO AT ANOTHER HOSPITAL. IT WAS REPORTED THAT THE PLATE AND SCREWS WERE INTACT PRIOR TO REMOVAL. DURING THE SURGERY, AFTER REMOVING THE FIRST SCREW WITHOUT ANY DIFFICULTY, THE TIP OF THE EXTRACTION INSTRUMENT BROKE WHILE ATTEMPTING TO REMOVE THE SECOND SCREW THAT WAS REPORTED AS STRIPPED. THE SURGEON WAS ABLE TO REMOVE BOTH BROKEN PIECES AND IT WAS CONFIRMED THAT THERE WERE NO OTHER FRAGMENTS. THE SURGEON INITIALLY TRIED SEVERAL DIFFERENT SCREWDRIVERS TO REMOVE THE SCREW AND THEN SWITCHED TO THE EXTRACTION INSTRUMENT. THE EXACT LENGTH OF DELAY IN THE SURGERY WAS UNKNOWN. IT WAS REPORTED THAT ONCE THE INSTRUMENT BROKE, THE SURGEON DID NOT TAKE ANY FURTHER ACTION. THEREFORE, THE PATIENT WAS CLOSED WITH ONE PLATE AND FIVE (5) SCREWS. POSTOPERATIVE PLANS ARE FOR THE PATIENT TO BE SEEN BY ANOTHER SURGEON FOR THE REMOVAL OF THE REMAINING DEVI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6289577 ↗