GAMMA 8166-0090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327591804), received between Jun 27, 2024 and Jul 28, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Fracture

  It was reported that, the primary surgery was performed on (b)(6)2025. The revision surgery was performed due to a cutout in the U-lug screw and damage to the U-blade. It was further confirmed that the U blade was broken. No further information was provided.

  Patient problems: Perforation

  MAUDE report 50061376 ↗
• InjuryJul 28, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  It was reported that, the primary surgery was performed on (b)(6) 2025. Revision surgery was performed due to a cutout in the U-lag screw and damage to the U-blade. No further information was provided.

  Patient problems: Perforation

  MAUDE report 50061364 ↗
• MalfunctionMar 19, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent

  AS REPORTED: "THE U-BLADE FAILED TO ENTER THE BLADE INSERTION GROOVE ON THE LUG WHEN INSERTING THE U-LAG SCREW. UPON REMOVAL, THE U-BLADE WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642499 ↗
• MalfunctionMar 6, 2026Material Twisted/Bent

  AS REPORTED: "WHEN ATTEMPTING TO HAMMER IN THE U-SHAPED LAG SCREW WHILE VIEWING THE SIDE PROFILE, THERE WAS SLIGHT RESISTANCE. UPON CHECKING THE FRONT VIEW, ONE SIDE OF THE U WAS BENT OUT OF SHAPE. THEREFORE, THE U-SHAPED LAG WAS REMOVED, THE LAG ITSELF WAS LEFT IN PLACE, AND THE U-LAG END CAP WAS TIGHTENED BEFORE CONTINUING THE OPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536366 ↗
• InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "ON (b)(6) 2025, ORIF USING GAMMA 4 DEVICE WAS PERFORMED. POSTOPERATIVELY, THE PATIENT WAS UNDERGOING REHABILITATION AT ANOTHER HOSPITAL. HOWEVER, THE PATIENT COMPLAINED OF PAIN ON THE OUTER SIDE OF THE LAG SCREW. AN X-RAY TAKEN ON (b)(6) 2025 REVEALED THAT THE END CAP OF THE U-LAG SCREW HAD BECOME LOOSE. REMOVAL OF THE LOOSE U-LAG SCREW END CAP WAS SUGGESTED, BUT THE PATIENT DECLINED. AS THE X-RAY IN DECEMBER SHOWED IT WAS STILL LARGELY IN PLACE, THE DOCTOR DECIDED CONTINUING FOLLOW-UP (MONITORING) WITHOUT REMOVAL SURGERY. THE X-RAY IMAGES WERE PROVIDED FROM THE FACILITY AS THEY ARE REQUESTING CLINICAL REVIEW OF THEM."

  Patient problems: Pain

  MAUDE report 24457955 ↗
• MalfunctionFeb 26, 2026Difficult to Open or Remove Packaging Material

  AS REPORTED: "DURING SURGERY, WHILST OPENING THE STERILE PACK OF THE U-LAG SCREW, THE NURSE ATTEMPTED TO GRASP THE CONTENTS WITH FORCEPS. HOWEVER, THE TEAR NOTCH ON THE PACK BROKE OFF, LEAVING ONLY THE END CAP TO FALL ONTO THE UNCLEAN FIELD. A NURSE REMARKED THAT THE PACKAGING DESIGN MIGHT MAKE THE END CAP PRONE TO DETACHING. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER ENDCAP FROM NEW U-LAG SCREW PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457746 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE FEMORAL HEAD WAS PENETRATED WITH THE LAG SCREW POSTOPERATIVELY. DURING THE INITIAL SURGERY, ALSO A PENETRATION OF THE FEMORAL HEAD OCCURRED, NECESSITATING REPLACEMENT OF THE IMPLANT.. THE SURGEON CONSIDERS THAT THE RECURRENCE OF FEMORAL HEAD PENETRATION POSTOPERATIVELY WAS CAUSED BY THIS EFFECT." THIS RECORD COVERS THE POST-OPERATIVE LAG SCREW PERFORATION.

  Patient problems: Perforation

  MAUDE report 23922211 ↗
• InjuryDec 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DUE TO THE CUTOUT, AN EXTRACTION ORDER WAS ISSUED. UPON ARRIVING TO WITNESS THE EXTRACTION, THE BLADE WAS FOUND BENT. IT WAS REPORTED THAT, THE NAIL WAS LEFT IN PATIENT AND DISTAL LATERAL FASTENER IN PLACE, ONLY THE RC LAG SCREW AND U-BLADE END CAP WERE REMOVED. THE BENT BLADE WAS CONFIRMED DURING REMOVAL. IT WAS UNCLEAR WHEN IT BENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 23830648 ↗
• InjuryOct 22, 2025Device Handling Problem; Device Handling Problem

  AS REPORTED: "DURING SURGERY WITH USING GAMMA 4 U-LAG SCREW, AS IT APPEARED THAT THE FEMORAL HEAD WERE SEPARATED BY HAMMERING IN THE U-BLADE."

  Patient problems: Bone Fracture(s)

  MAUDE report 23357373 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6)2025. 4 MONTHS AFTER SURGERY, IT WAS FOUND THAT THE LAG SCREW WAS CUT-THROUGH. REVISION SURGERY FOR REMOVING IMPLANTS AND REPLACING TO THA IS SCHEDULED ON (B)(6)2025."

  Patient problems: Perforation

  MAUDE report 23254363 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AS REPORTED: "U BLADE WAS INSERTED MANUALLY, BUT DID NOT FOLLOW THE RAILS OF THE LAG SCREW, AND THE U BLADE WAS BENT IN THE WRONG DIRECTION ON THE ML VIEW OF X-RAY. REMOVED THE U-BLADE, BUT COULD NOT USE IT BECAUSE THE BLADE WAS BENT. THE LAG WAS REMOVED ONCE, AND A NEW 95 MM U-LAG WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885184 ↗
• MalfunctionJul 22, 2025Fracture; Material Deformation; Fracture; Material Deformation

  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 JUNE 27, 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565133 ↗
• InjuryJul 9, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE PATIENT DEVELOPED HIVES ON (B)(6) 2025 AND THE DOCTOR REPORTED THAT HE SUSPECTED A METAL ALLERGY CAUSED BY THE IMPLANT. THE DOCTOR REQUEST US TO PROVIDE THE INGREDIENTS LIST IN THE TITANIUM ALLOY OF THE IMPLANTS."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22457536 ↗
• MalfunctionJul 8, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN INSERTING THE U-BLADE WITH HAMMER, THE LAG SCREW WENT TOGETHER WITH THE U-BLADE JUST TO THE TIP OF THE FEMORAL HEAD. THE U- LAG SCREW WAS REPLACED TO THE 85MM ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441502 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. AFTER SURGERY CUTOUT OCCURRED. REVISION SURGERY (REPLACE TO BHA) WAS PERFORMED ON (B)(6) 2025."

  Patient problems: Perforation

  MAUDE report 21922034 ↗
• InjuryDec 23, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  INTRAOPERATIVELY, THE SALES REP WAS INFORMED BY PHONE THAT ¿WHEN THE U BLADE WAS TAPPED, THE LAG SCREW ENTERED DEEPLY INTO THE PELVIC DIRECTION". THE SALES REP INSTRUCTED THE SURGEON TO REMOVE THE LAG SCREW AND RETRY THE PROCEDURE AGAIN. FINALLY, THE SURGERY WAS FINISHED. IT WAS FOUND THAT THIS WAS CAUSED BY AN ATTEMPT TO INSERT THE U-BLADE WITH THE LAG SCREWDRIVER HANDLE HORIZONTAL TO THE TARGET DEVICE. AS A RESULT, THE SET SCREW WAS ALSO NOT PROPERLY FIXED, RESULTING IN THE LAG SCREW BEING PUSHED INWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21009074 ↗
• MalfunctionDec 4, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "INTRAOPERATIVELY, THE GAMMA 4 U-LAG BLADE WAS BROKEN. THE DOCTOR CALLED SALES REP INTRAOPERATIVELY AND SAID THAT HE HAD DECIDED TO END THE PROCEDURE WITHOUT THE BLADE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849863 ↗
• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A CUTOUT HAD OCCURRED. REVISION SURGERY.

  Patient problems: Perforation

  MAUDE report 20100950 ↗
• InjuryAug 23, 2024Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  T WAS REPORTED THAT DUE TO THE MALFUNCTION OF THE DEVICE, WHICH LED TO INTRA-OPERATIVE EVENT THAT RESULTED IN ADDITIONAL LARGER INCISION AND DEVICE REPLACEMENT. THE ACTUAL SEVERITY OF S2 WAS ASSIGNED TO THE HARM OF THE COMPLAINT BECAUSE THE REPORTED EVENT LED TO A MINOR INTRA-OP INTERVENTION TO PREVENT PERMANENT IMPAIRMENT.

  Patient problems: Perforation

  MAUDE report 20052033 ↗
• InjuryJun 27, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING THE INSERTION OF THE GAMMA 4 U LAG SCREW, COMPRESSION WAS APPLIED BY GENTLY HITTING IT WITH A HAMMER, BUT THE COMPRESSED FRACTURE AREA BECAME DEVIATED. SURGEON WAS NOT SATISFIED WITH THE GAP (NON UNION) PRESENT IN COMPRESSED FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19625781 ↗