GAMMA 8125-0170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327479058), received between Dec 14, 2023 and Sep 30, 2026 — classified as 13 injuries, 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952919 ↗
• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917221 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER THE INTRAOPERATIVE NAIL HAD BEEN INSERTED AND AN X-RAY WAS TAKEN PRIOR TO WOUND CLOSURE, A BONE FRACTURE WAS DETECTED; CONSEQUENTLY, THE SHORT NAIL HAD TO BE REMOVED, THE CABLE WOUND AROUND IT, AND THE NAIL REPLACED WITH A LONGER ONE. BECAUSE THE CABLE WAS USED WITH THE LONG NAIL, WOUND WAS LARGER THAN INITIAL."

  Patient problems: Limb Fracture

  MAUDE report 25618467 ↗
• MalfunctionMay 12, 2026Positioning Failure

  AS REPORTED: "DURING THE SHORT NAIL SURGERY, THE DRILL USED TO INSERT THE DISTAL SCREW SLIPPED OUT OF THE HOLE. THE SURGEON RE-DRILLED THE SITE AND SUCCESSFULLY INSERTED THE SCREW. AN UNNECESSARY HOLE WAS DRILLED IN THE BONE".

  Patient problems: Perforation

  MAUDE report 25153235 ↗
• MalfunctionMar 23, 2026Malposition of Device

  AS REPORTED: "A MIS-DRILL OCCURRED DURING DISTAL LOCKING. PREOPERATIVE TARGET ACCURACY CHECK SHOWED NO PROBLEMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661507 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE U-BLADE WAS DIFFICULT TO INSERT, AND WHILE ATTEMPTING TO DRIVE IT IN WITH A HAMMER, THE LAG SCREW PERFORATED THE FEMORAL HEAD AND ADVANCED INTO THE ACETABULUM." THE NAIL AND LAG SCREW WERE REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 23869631 ↗
• MalfunctionDec 17, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "AFTER THE U-LAG SCREW WAS INSERTED, THE SET SCREW WAS NOT TIGHTENED PROPERLY, CAUSING THE U-LAG SCREW TO ROTATE. FURTHERMORE, IN THIS STATE, THE SCREWDRIVER WAS FORCEFULLY PULLED OUT FROM THE END CAP OF THE U-LAG SCREW, CAUSING THE ENTIRE LAG SCREW TO COME OUT TO LATERAL. THE LAG SCREW WAS REINSERTED INTO THE OPTIMAL POSITION, AND THE SET SCREW WAS TIGHTENED. PROLONGED ANESTHESIA TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828117 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE EXACT DATE OF THE INCIDENT IS UNCERTAIN, BUT A PATIENT WHO UNDERWENT GAMMA 4 SURGERY SUFFERED A CERVICAL FRACTURE SEVERAL MONTHS LATER. IT IS PLANNED TO REPLACE IT WITH AN ARTIFICIAL BONE HEAD AT A LATER DATE. INITIALLY ABLE TO WALK INDEPENDENTLY INDOORS, BUT BEGAN EXPERIENCING PAIN AND NOW WALKS WITH A CANE. THE IMPLANT WAS REMOVED ON (B)(6) 2025."

  Patient problems: Ambulation or Postural Difficulties; Limb Fracture; Pain; Perforation

  MAUDE report 23720157 ↗
• InjuryNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT A GAMMA NAIL BROKE DISTALLY AND THE PATIENT HAD TO GO IN FOR A REVISION BUT IT WAS A NON UNION AND HE HAD FALLEN AGAIN.

  Patient problems: Fall; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23550491 ↗
• InjuryNov 5, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "A GAMMA4 U-LAG SCREW PERFORATED THE PELVIS. THE PATIENT REPORTED PAIN AND THIS RESULTED IN A REVISION SURGERY." ADDITIONAL INFORMATION: AROUND OCTOBER 5TH, THE PAIN IN THE LEFT HIP JOINT GRADUALLY WORSENED AND INCREASED DURING REHABILITATION. WHEN THE SURGEON RE-CHECKED THE X-RAY, IT REVEALED THAT THE LAG SCREW HAD PERFORATED THE PELVIS. IT WAS REPORTED THAT DURING PRIMARY SURGERY, THE SET SCREW WAS NOT TIGHTENED WHEN INSERTING THE U-LAG, AND THE U-BLADE WAS INSERTED WITHOUT X-RAY CONFIRMATION.

  Patient problems: Pain; Perforation

  MAUDE report 23477347 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AFTER BEING DISCHARGED FROM THE HOSPITAL, CUTOUT WAS CONFIRMED AT A REGULAR CHECKUP IN SEPTEMBER. THE PATIENT REPORTED THAT SHE HAD FALLEN DURING REHABILITATION IN AUGUST AND FELT PAIN AFTER THAT.".

  Patient problems: Fall; Pain; Perforation

  MAUDE report 23407353 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT WHO UNDERWENT ORIF (GAMMA 4) AT ANOTHER HOSPITAL ON (B)(6) 2025. AT AN UNKNOWN TIME, THE LAG SCREW CUT OUT THE FEMORAL HEAD. ON (B)(6) 2025, GAMMA4 WAS REMOVED AND BHA WAS PERFORMED. PREOPERATIVE X-RAYS CONFIRMED THAT THE BLADE OF THE U-LAG SCREW WAS SIGNIFICANTLY BENT. AFTER REMOVAL, RE-EXAMINATION OF THE IMPLANT CONFIRMED THAT, AS SEEN ON X-RAY, THE BLADE WAS SIGNIFICANTLY BENT."

  Patient problems: Perforation

  MAUDE report 23404907 ↗
• 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 23254414 ↗
• MalfunctionJul 25, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "BECAUSE THE LAG SCREW WAS SHORTER, THE SURGEON REPLACED IT WITH LONGER ONE. AT THAT TIME, THE SET SCREW WAS LOOSENED ONCE, AND AFTER THE LAG SCREW WAS REPLACED, THE SURGEON ATTEMPTED TO TIGHTEN THE SET SCREW AGAIN. HOWEVER, THE SET SCREW WOULDN'T TIGHTEN. THUS, THE WHOLE NAIL WAS REMOVED FROM THE PATIENT AND NEW NAIL WAS OPENED AND WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OCCURRED, BUT THE OPERATION TIME WAS EXTENDED BY 30 MINUTES TO REPLACE THE NAIL. THE SURGEON TRIED TO TIGHTEN THE SET SCREW AGAIN OUTSIDE OF PATIENT'S BODY USING THE REMOVED NAIL, AND IT WOULD TIGHTENED. WHEN HE TRIED TO DO THIS SEVERAL TIMES, SOMETIMES IT WOULDN'T TIGHTEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613758 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE GAMMA 4 SHORT NAIL WAS IMPLANTED, AND POST-CLOSURE X-RAY WAS PERFORMED BEFORE THE PATIENT WOKE UP FROM ANESTHESIA. THE X-RAY REVEALED A FRACTURE IN A SPOT THAT WAS NOT THERE PREOPERATIVELY, SO ANESTHESIA WAS CONTINUED SUDDENLY AND REPLACEMENT OF THE SHORT NAIL WITH THE LONG NAIL WAS PERFORMED. NO PATIENT INJURIES OCCURRED, BUT THE PROCEDURE TIME WAS EXTENDED BY JUST OVER 60 MINUTES."

  Patient problems: Bone Fracture(s)

  MAUDE report 22555297 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: 002-042. STRYKER PEGASUS STUDY. (B)(6) 2025, NON-UNION (NO BONE CONSOLIDATION WITHIN 6MONTHS). XRAYS TAKEN ON (B)(6) 2025 SHOW THAT BONE IS NOT HEALED. FOLLOW-UP BLOOD TESTS AND CT SCAN ORDERED. PLAN FOR PATIENT TO RETURN TO CLINIC IN THREE WEEKS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22327157 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  AS REPORTED: "THE GAMMA4 DEVICE AND THE NAIL ARE NO LONGER DISCONNECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354705 ↗
• MalfunctionDec 9, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  INTRAOPERATIVELY, 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 20887337 ↗
• 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 20101318 ↗
• InjuryDec 19, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A GAMMA4 INTERMEDIATE NAIL IN COMBINATION WITH AN RC LAG SCREW AND WITH USE OF THE ANTI-ROTATION CLIP FOR TREATMENT OF AN UNSTABLE FRACTURE IN THE TROCHANTERIC REGION. HE TOOK OUT THE SHORT NAIL AND PUT IN A LONGER NAIL. FOLLOWING INFORMATION WAS RECEIVED FROM THE SALES REP: "THE PREVIOUS NAIL WAS A STRYKER GAMMA4 NAIL THAT WAS INCORRECTLY POSITIONED AND CUT-OUT. THE SURGEON ELECTED TO REVISE IT AND ADDED A LONGER NAIL."

  Patient problems: Perforation

  MAUDE report 18353901 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "GAMMA 4 PRIMARY SURGERY WAS PERFORMED AT (B)(6) 2023. THE PATIENT FALL AT (B)(6) 2023 AND REFRACTURE AT THE END OF THE NAIL WAS OCCURRED. REVISION SURGERY WITH GAMMA3 LONG NAIL AND U-LAG SCREW WAS PERFORMED AT (B)(6) 2023."

  Patient problems: Fall; Limb Fracture

  MAUDE report 18326177 ↗