GALILEO™ LAG SCREW, RIGHT, 10.5mm x 95mm 1099-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848665015843), received between Aug 18, 2023 and May 15, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Break

  IT WAS REPORTED THAT A FEW DAYS AFTER THE IMPLANTATION OF A TROCHANTERIC NAIL, IT WAS DISCOVERED THAT THE LAG SCREW HAD BROKEN INTO THE JOINT. THERE WAS NO SPECIFIC INCIDENT THAT HAD LED TO THE FRACTURE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 08-MAY-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2026, AND THE REVISION SURGERY ON (B)(6) 2026. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON. THE PATIENT HAS NO FURTHER SYMPTOMS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25191213 ↗
• MalfunctionMay 15, 2026Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN A FEW DAYS AFTER THE IMPLANTATION OF A TROCHANTERIC NAIL ON (B)(6) 2026. AN X-RAY WAS SUBSEQUENTLY TAKEN, WHICH SHOWED THAT THE LAG SCREW AND THE ANTI-ROTATION SCREW HAD FRACTURED INTO THE JOINT. THERE WAS NO SPECIFIC INCIDENT THAT HAD LED TO THE FRACTURE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Pain

  MAUDE report 25187053 ↗
• InjuryOct 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 09/03/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 5033-100 CAPTURING ROD ASSEMBLY WAS COLD-WELDED WITH THE SCREW. THIS OCCURRED DURING A REVISION TROCH NAIL PROCEDURE WHEN THE SURGEON REMOVED OUR TROCH NAIL AND IMPLANTED A SYNTHES NAIL WHEN THE GALILEO CAPTURING ROD COLD WELDED TO THE SCREW UPON REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 20522252 ↗
• MalfunctionJul 23, 2024Break; Break

  ON 7/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 1099-095 TELESCOPING LAG SCREW LOCKING MECHANISM BROKE WHEN TRYING TO LOCK IT. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING A 1099-090 TELESCOPING LAG SCREW. THIS WAS DISCOVERED DURING A TROCHANTERIC NAIL PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19805941 ↗
• MalfunctionDec 22, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ON 11/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1099-095 TELESCOPING LAG SCREW RING WAS PROMINENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18385469 ↗
• MalfunctionNov 22, 2023Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth; Positioning Failure; Loosening of Implant Not Related to Bone-Ingrowth

  ON 10/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A TROCHANTERIC NAIL PROCEDURE ON 6/4/2023. AFTER THE SURGERY, AN X-RAY REVEALED THAT THE 1099-095 LAG SCREW SHIFTED LATERALLY. THE PATIENT IS NOT IN ANY DISCOMFORT OR PAIN, AND THE IMPLANTS REMAIN IN PLACE. CAUSE FOR THE SHIFT IN THE LAG SCREW IS UNKNOWN.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 18190910 ↗
• InjuryNov 1, 2023Break; Break

  ON 10/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT SURGERY DUE TO AN INTERTROCHANTERIC FRACTURE ON (B)(6) 2023. ON (B)(6) 2023, THE SALES REPRESENTATIVE WAS MADE AWARE VIA PHONE THAT THE LAG SCREW IMPLANTED IN THE PATIENT BROKE. THE PATIENT WILL UNDERGO REVISION SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 10/13/2023: ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY IN WHICH A 1023-395 TROCHANTERIC NAIL AND A 1099-095 LAG SCREW WERE IMPLANTED. ON (B)(6) 2023, THE PATIENT FELT PAIN WHILE WALKING. A REVISION SURGERY TOOK PLACE ON (B)(6) 2023 TO REMOVE THE TROCH NAIL AND LAG SCREW. DURING THE REMOVAL OF THE LAG SCREW, IT WAS NOTICED THAT IT HAD SCRATCHES DISTAL TO THE THREADS. THE CASE WAS COMPLETED AS A TOTAL HIP ARTHROPLASTY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 18046633 ↗
• MalfunctionAug 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 7/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 1099-095 TELESCOPING LAG SCREW WAS BEING REMOVED, AND AS THE SURGEON WAS BACKING THE SCREW OUT, THE LOCKING RING GOT CAUGHT ON THE LATERAL CORTEX. THE SURGEON HAD TO RIP THE LAG SCREW THROUGH THE LOCKING RING, WHICH WAS EMBEDDED IN THE CORTEX. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17577011 ↗