GAMMA 8525-0360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327474619), received between Feb 27, 2024 and Mar 26, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A LONG GAMMA 4 NAIL IMPLANTED FOLLOWING A LEFT INTERTROCHANTETIC HIP FRACTURE IN (B)(6) OF 2025. THE PATIENT LATER REPORTED EXPERIENCING INCREASED PAIN. A FOLLOW UP X-RAY SEEMED TO INDICATE A FRACTURED NAIL. THE DEVICE WAS SUBSEQUENTLY REVISED, AND A RESTORATION MODULAR TOTAL HIP PROSTHESIS WAS IMPLANTED. IT WAS ALSO REPORTED THAT THERE WAS S A POTENTIAL NON-UNION.

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

  MAUDE report 24698842 ↗
• MalfunctionFeb 6, 2026Malposition of Device

  AS REPORTED: "DURING THE GAMMA4 LONG NAIL TECHNIQUE, AFTER INSERTING THE NAIL, WHEN ATTEMPTING TO INSERT THE LAG SCREW, THE PRECISION PIN WAS INSERTED BUT COULD NOT BE POSITIONED CORRECTLY. DESPITE CAREFULLY DRILLING FOR THE LAG SCREW WITHOUT A GUIDE PIN, IT WAS IMPOSSIBLE TO DRILL TO THE APPROPRIATE DEPTH BEYOND THE LAG SCREW HOLE. AS THE DRILL SIMPLY WOULD NOT PASS THROUGH, THE PRECISE LENGTH OF THE LAG SCREW COULD NOT BE DETERMINED. AN APPROXIMATE LENGTH WAS ESTIMATED AND THE LAG SCREW INSERTED, BUT IT TOO STOPPED MIDWAY. AFTER SWITCHING TO A NAIL WITH A DIFFERENT NECK ANGLE AND REINSERTING IT, WE WERE ABLE TO PLACE IT IN THE OPTIMAL POSITION. POSTOPERATIVELY, CALIBRATION USING THE TARGETING DEVICE, NAIL, AND LAG SCREW EMPLOYED FOR INSERTION REVEALED NO ISSUES. CONSEQUENTLY, THE SURGEON CONCLUDED THAT THE DEVICE HAD DEFLECTED DUE TO THE PATIENT'S BONE QUALITY AND SHAPE, PREVENTING INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277550 ↗
• InjuryJun 17, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "POOR BONE UNION AFTER INITIAL SURGERY WITH GAMMA4. REVISION BHA SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO G4 NAIL FRACTURE. DURING THE INITIAL SURGERY, THE BONE WAS FIXED IN A SLIGHTLY VARUS POSITION. NON-UNION OCCURRED, RESULTING IN A G4 NAIL FRACTURE AT THE LAG SCREW POSITION."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22242379 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). STRYKER PEGASUS STUDY. DEEP VEIN THROMBOSIS. ACUTE DVT (LEFT PERONEAL VEIN) DIAGNOSED AT ED ON 23/AUG/2023 AFTER A FEW DAYS OF WORSENING LEG SWELLING AND PAIN. DIAGNOSIS VIA ULTRASOUND. PATIENT MEDICATION CHANGED FROM HEPARIN TO ELIQUIS AND DISCHARGED SAME DAY. BY ORTHOPEDIC F/U ON 18/SEP/2023 PATIENT WAS SYMPTOM-FREE."

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21993350 ↗
• InjuryApr 8, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED: "A GAMMA4 NAIL IMPLANTED ABOUT 3 MONTHS AGO FAILED AT THE LAG SCREW SITE. THE NAIL WAS COMPLETELY BROKEN INTO 2 PIECES AT THIS POINT IN THE NAIL. OCCURRED WHILE THE PATIENT WAS USING A STATIONARY BIKE. PATIENT HAD TO HAVE A REOPERATION DUE TO THE IMPLANT FAILURE. IMPLANT WAS REMOVED AND REPLACED WITH A TROCH NAIL FROM A DIFFERENT COMPANY."

  Patient problems: Failure of Implant

  MAUDE report 19068083 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: CLINICAL STUDY PEGASUS SUBJECT (B)(4). ADVERSE EVENT: PAIN. PATIENT EXPERIENCING SYMPTOMS OF GREATER TROCHANTERIC BURSITIS, POSSIBLY FROM HER PROMINENT LAG SCREW ON THE LATERAL BORDER OF THE FEMUR FOLLOWING FX COMPRESSION PATIENT PREVIOUSLY ACHIEVED BONE CONSOLIDATION AT 3 MONTH VISIT ((B)(6) 2023) BOTH CLINICALLY AND RADIOGRAPHICALLY.

  Patient problems: Bursitis; Implant Pain

  MAUDE report 18790254 ↗