GAMMA 8166-0085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327591798), received between Jul 23, 2024 and Jul 31, 2026 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101154 ↗
• InjuryMar 24, 2026Material Twisted/Bent

  AS REPORTED: ON (B)(6) 2025, PRIMARY SURGERY WITH GAMMA4 WAS PERFORMED.AFTER SURGERY, A CUT-OUT OF THE U-LAG SCREW OCCURRED, AND SCREW REMOVAL SURGERY WAS PERFORMED. DURING THE PROCEDURE, IT WAS FOUND THAT THE BLADE OF THE U-LAG SCREW WAS BENT OUTWARD.

  Patient problems: Perforation

  MAUDE report 24676667 ↗
• InjuryMar 19, 2026Malposition of Device

  AS REPORTED: "WHILE HAMMERING THE U-BLADE INTO PLACE, IT APPEARED THE LAG WAS DRIVEN TOO FAR, PENETRATING THE BONE HEAD AND REACHING THE ACETABULUM. THE LAG WAS REPOSITIONED TO THE INDICATED LOCATION, AND THE OPERATION CONCLUDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640122 ↗
• InjuryJan 30, 2026Migration

  AS REPORTED: "GAMMA, U-LAG SCREW INSERTION: POSSIBILITY OF SET SCREW NOT BEING TIGHTENED, LAG INSERTED UP TO THE BELLY." REMOVAL OF LAG SCREWS VIA OPEN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 24222433 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE BLADE WAS INSERTED INCORRECTLY AND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040485 ↗
• MalfunctionDec 29, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent

  AS REPORTED: "DURING THE GAMMA4 PROCEDURE, THE CAP FOR THE U-LUG SCREW COULD NOT BE INSERTED PROPERLY. ATTEMPTING TO REATTACH THE CAP, IT BECAME STUCK ON THE SCREWDRIVER TIP AND COULD NOT BE REMOVED. IT WAS EVENTUALLY EXTRACTED USING PLIERS. THE THREAD ON THE U-LUG END CAP WAS CRUSHED BY THE PLIERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917959 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE LAG SCREW CUT OUT. THE PATIENT HAD BEEN FOLLOWING INSTRUCTIONS. HOWEVER, THIS TIME IT WAS TRAUMATIC AVASCULAR NECROSIS CAUSED BY A FALL. THE EVENT WAS DISCOVERED ON (B)(6) 2025 AND THE NAIL WAS REMOVED AND AN ARTIFICIAL HEAD WAS IMPLEMENTED ON (B)(6) 2025.".

  Patient problems: Fall; Necrosis; Perforation

  MAUDE report 23219830 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER THE OPERATION, IT WAS CUT OUT."

  Patient problems: Perforation

  MAUDE report 23175398 ↗
• MalfunctionJul 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "ORIF FOR LEFT FEMORAL FRACTURE. STRYKER SALEREP DID NOT PARTICIPATE IN THE SURGERY, BUT WAS CONTACTED BY THE SURGEON AFTER THE PROCEDURE. DURING SURGERY, AN 85 MM U-LUG SCREW WAS SELECTED, BUT WHEN ATTEMPTING TO INSERT THE U-BLADE, IT DID NOT GO IN COMPLETELY. X-RAY CONFIRMATION REVEALED THAT THE BLADE WAS BROKEN. THE SURGEON REMOVED THE BROKEN PIECE FROM THE BODY. THE SCREW WAS CHANGED TO A 90MM SCREW AND IMPLANTED. THE BLADE COULD BE INSERTED, BUT THE U-LAG SCREW CAP DID NOT FIT. THE SURGEON REMOVED THE BLADE FOR INSPECTION AND FOUND IT DEFORMED INWARD. THE SURGEON ABANDONED THE ATTEMPT TO INSERT THE U-LAG SCREW AND INSTEAD INSERTED A STANDARD 85MM LAG SCREW, CONCLUDING THE PROCEDURE. ACCORDING TO THE NURSE, SHE DOES NOT RECALL USING THE GAMMA 4U GUIDE (14203010) DURING THE PROCEDURE. SHE BELIEVES THAT THE BLADE WAS ATTACHED TO THE GAMMA 4 INSERTER (14203020) WITHOUT THE U GUIDE AND INSERTED INTO THE LAG SCREW WITHOUT THE U GUIDE. UPDATE ON (B)(6) 2025 88-YEAR-OLD FEMALE BONE QUALITY: FRAGILE IN THE PREVIOUS REPORT, THE NURSE SAID THAT SHE DID NOT REMEMBER PUTTING ON THE GAMMA 4 U-GUIDE, BUT THE DOCTOR SAID THAT SHE DID INDEED PUT ON THE U-GUIDE AND CONFIRMED THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564952 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUTOUT OCCURRED AFTER PROCEDURE.

  Patient problems: Perforation

  MAUDE report 21595216 ↗
• InjuryFeb 19, 2025Migration; Migration

  AS REPORTED: "GAMMA4 U-LAG SCREW PENETRATION WAS OCCURRED".

  Patient problems: Perforation

  MAUDE report 21417489 ↗
• MalfunctionJan 9, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  AS REPORTED: "AFTER COMPRESSION, A U-LAG SCREW WAS INSERTED. THE FRACTURE AREA WAS NOT CLOSED. DR'S OPINION THAT THE TECHNIQUE OF HAMMERING THE U-LAG SCREW MAY HAVE CAUSED THE FRACTURE SEPARATED. THE INSERTER WAS ONLY REPORTED AS A COMBINATION INSTRUMENT AND HAS NO DEFECTS".

  Patient problems: Insufficient Information

  MAUDE report 21119089 ↗
• MalfunctionDec 4, 2024Positioning Failure; Malposition of Device; Positioning Failure; Malposition of Device

  IT WAS REPORTED: "GAMMA 4 INTERMEDIATE NAIL AND U-LAG SCREW WERE USED FOR A FEMORAL TRANSVERSE FRACTURE. THE REDUCTION POSITION WAS VERY GOOD, AND COMPRESSION WAS ALSO FULLY APPLIED. BUT WHEN THE U BLADE WAS HAMMERED IN, THE FRACTURE SITE WAS SEPARATED AGAIN. AFTER THAT, THERE WAS NOTHING THE SURGEON COULD DO, AND THE SURGERY WAS FINISHED AS IT WAS".

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 20849809 ↗
• MalfunctionNov 21, 2024Break; Positioning Failure; Fracture; Material Twisted/Bent; Break; Positioning Failure; Fracture; Material Twisted/Bent

  DURING GAMMA 4 SURGERY, THE LAG SCREW REPLACEMENTS OCCURRED TWICE. THE FIRST TIME, WHEN A U-LAG SCREW (8166-0080S) OF THE VALUE OBTAINED AT THE TIME OF MEASUREMENT WAS INSERTED, IT WAS PLACED IN A SHORTER POSITION THAN EXPECTED. THE U-LAG SCREW (8166-0085S), ONE SIZE LONGER, WAS REPLACED AND REINSERTED. THE LENGTH WAS FINE, BUT WHEN COMPRESSION WAS APPLIED INTRAOPERATIVELY, COMPRESSION WAS NOT APPLIED AS EXPECTED. THE COMPRESSION OPERATION WAS STOPPED MIDWAY AND THE U-BLADE WAS INSERTED. AFTER THAT, DURING BLADE INSERTION THE BLADE WAS BENT. WHEN THE BLADE WAS REMOVED, THE BLADE WAS BROKEN IN THE MIDDLE. FINALLY, THE SURGERY WAS SUCCESSFULLY COMPLETED BY REPLACEMENT TO A REGULAR LAG SCREW (8160-0085S), INSTEAD OF USING THE U-LAG SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748448 ↗
• InjuryJul 23, 2024Malposition of Device; Malposition of Device

  THE GAMMA 4 U BLADE INSERTED USING HAMMERING SENSATION BY SURGEON RESULTS IN PERFORATION OF FEMORAL HEAD.

  Patient problems: Perforation

  MAUDE report 19803988 ↗