NA 207.752Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982148568), received between Nov 26, 2019 and Mar 5, 2024 — classified as 3 malfunctions.

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

• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON INSERTED A 4.00MM CANNULATED SCREW WITH LONG THREAD INTO THE PATIENT¿S FEMUR, AND NOTICED THAT THE THREAD WAS BROKEN OFF. THE SCREW WAS SUCCESSFULLY REMOVED WITHOUT THE THREADED PORTION, AND THE THREAD WAS REMOVED WITH THE BROKEN SCREW REMOVAL SET. A NEW SCREW WAS INSERTED. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - SCREWS: 4.0 MM CANNULATED . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837477 ↗
• MalfunctionDec 27, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN MALAYSIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PIECE OF THE SCREW WAS BROKEN IN A PATIENT¿S BONE. ACCORDING TO THE X-RAYS, WIRE WAS NOT BENT AND CONFIRMED THROUGH II MACHINE BEFORE INSERTING THE SCREW. HOWEVER, AS THE SURGEON HAND-TIGHTENED THE SCREW, AND THE SCREW WAS BROKEN AND LEFT IN THE PATIENT¿S BONE AND COULD NOT BE REMOVED. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS NOT SUCCESSFULLY COMPLETED; THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE 4.0MM CANNULATED SCREW-LONG THREAD 52MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18397613 ↗
• MalfunctionNov 26, 2019Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE DOCTOR DECIDED TO POWER THE 4.0 CANNULATED SCREW IN, AND THE THREAD OF SCREW SCUFFLED AND KIND OF UNWOUND, AND SPUN ALL OVER. THE WAS ABLE TO BE RETRIEVED FROM THE PATIENT AND THEN ANOTHER SCREW WAS PUT IN. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: HANDPIECE POWERED DRIVER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.0 MM CANNULATED SCREW 52 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377696 ↗