GAMMA 8125-1170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327478877), received between Oct 22, 2024 and Aug 20, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "The patient returned to the hospital from a rehabilitation facility due to pain. Radiographic examination demonstrated cut-out of the SHS (Sliding Hip Screw) in a Gamma 4 nail. On 08-Jun, revision surgery was performed with implantation of a hip endoprosthesis."

  Patient problems: Pain; Perforation

  MAUDE report 50359650 ↗
• MalfunctionJul 10, 2026Malposition of Device

  The following information was reported:Medial migrating of the lag screw withing Gamma4 intermediate nail.

  Patient problems: Insufficient Information

  MAUDE report 25785150 ↗
• InjuryJun 18, 2026Positioning Failure; Device Damaged by Another Device; Scratched Material

  THE SALES REP REPORTED THAT WHEN IN USE, THE REAMER OSCILLATES ABNORMALLY. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS COMPLETED, BUT THE OPERATING TIME WAS EXTENDED. THIS HAD AN IMPACT ON THE PATIENT, AS THE DRILL BIT RUBBED AGAINST THE NAIL, CAUSING TITANIUM DEBRIS TO ENTER THE PATIENT¿S BODY. TWO MOTORS WERE USED TO VERIFY THAT THE PROBLEM WAS NOT WITH THE DRILL CHUCK, BUT THE ISSUE PERSISTED. FOR THE PATIENT, THERE WAS AN INCREASED RISK OF INFECTION DUE TO THE LONGER PROCEDURE TIME AND MORE FREQUENT ENTRIES AND EXITS FROM THE OPERATING ROOM. INCREASED STERILIZATION VOLUME, LONGER OPERATING ROOM OCCUPANCY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25548423 ↗
• MalfunctionJun 17, 2026Positioning Failure; Device Damaged by Another Device

  AS REPORTED: "NAIL GOT DRILL-MARKED".

  Patient problems: Insufficient Information

  MAUDE report 25537872 ↗
• MalfunctionApr 1, 2026Mechanical Jam

  THE CUSTOMER REPORTED THAT: "THE GAMMA NAIL GOT STUCK IN ITS NAIL HOLDER. IT WAS IMPOSSIBLE TO UNSCREW IT. SEE ATTACHED PHOTOS. THE PROCEDURE HAD TO BE REPEATED, REMOVING THE CERVICAL AND DISTAL SCREWS AND THE NAIL, USING A NEW NAIL HOLDER AND NEW IMPLANTS. THE NAIL CANNOT BE SEPARATED FROM ITS NAIL HOLDER AND IS SENT FOR STERILIZATION MOUNTED ON THE NAIL HOLDER. THIS RESULTS IN WASTED TIME, A LONGER PROCEDURE, AND EXCESSIVE USE OF MATERIALS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24759398 ↗
• InjuryMar 30, 2026Positioning Failure; Malposition of Device

  THE CUSTOMER REPORTED THAT : "INSERTION OF A SHORT GAMMA NAIL IN A PATIENT SUFFERING FROM A LEFT INTERTROCHANTERIC FRACTURE. DATE: (b)(6)2026. SURGERY PROCEEDED WITHOUT INCIDENT, WITH POSTOPERATIVE X-RAYS TAKEN IMMEDIATELY AFTER SURGERY AND THEN THREE DAYS POSTOPERATIVELY, AS EXPECTED. THE PATIENT UNDERWENT THE USUAL POSTOPERATIVE MOBILIZATION. ONE MONTH LATER, THE PATIENT RETURNED FOR CONSULTATION DUE TO PAIN AND FUNCTIONAL IMPAIRMENT. THE X-RAY TAKEN AT THAT TIME SHOWED THAT THE CERVICAL SCREW OF THE NAIL HAD MIGRATED INTO THE SMALL PELVIS AND THAT THERE WAS NO CONTACT BETWEEN THE NAIL AND THE CERVICAL SCREW, DESPITE INTERNAL LOCKING HAVING BEEN PERFORMED IN ACCORDANCE WITH THE LABORATORY'S SURGICAL TECHNIQUE. THE PATIENT WAS HOSPITALIZED. THE PATIENT UNDERWENT A SECOND OPERATION TO REMOVE THE MATERIAL AND INSERT A HIP PROSTHESIS."

  Patient problems: Ambulation or Postural Difficulties; Implant Pain

  MAUDE report 24731891 ↗
• InjuryDec 30, 2025Migration; Migration

  AS REPORTED: "THE SET SCREW CAME LOOSE FROM THE GAMMA 4 NAIL. THE DOCTOR DOESN'T KNOW WHEN IT CAME LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922051 ↗
• MalfunctionOct 27, 2025Positioning Failure; Device Damaged by Another Device; Positioning Failure; Device Damaged by Another Device

  AS REPORTED: "CUSTOMER WAS NOT ABLE TO HIT THE NAIL CORRECTLY WITH THE FEMORAL NECK SCREW DRILL. THE NAIL WAS HIT WITH THE DRILL, THIS ALSO HAPPENED WITH THE SECOND NAIL. THE NAIL HOLDING SCREWS SHOW SIGNS OF WEAR.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389627 ↗
• InjuryOct 20, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, XRAY IMAGE WAS THEN TAKEN ON (B)(6) 2025, ISSUE WAS FOUND THAT THE SHS MIGRATED MEDIALLY. EACH OPERATION WAS PERFORMED BY A DIFFERENT DOCTOR/CLINICAL TEAM; REVISION SURGERY PERFORMED ON (B)(6) 2025."

  Patient problems: Perforation

  MAUDE report 23342890 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE GAMMA NAIL HAS MIGRATED UPWARDS, WHILE THE FEMORAL HEAD INCLUDING NECK HAS COLLAPSED DOWNWARD, EVEN THOUGH THE GAMMA4 NAIL WAS IN PLACE." A REVISION SURGERY WAS REQUIRED.

  Patient problems: Perforation

  MAUDE report 22742581 ↗
• InjuryJun 20, 2025Migration; Migration

  SUBJECT: (B)(6). STRYKER PEGASUS STUDY. MIGRATION PIN MIGRATED THROUGH BONE INTO MUSCLE. RELATIONSHIP TO DEVICE: DEFINITELY RELATED, RELATIONSHIP TO PROCEDURE: DEFINITELY RELATED.

  Patient problems: Insufficient Information

  MAUDE report 22297712 ↗
• 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. PAIN: PATIENT HAS SOME SORENESS LATERALLY CONSISTENT WITH IRRITATION FROM THE LAG SCREW AFTER THE FRACTURE HEAD COMPRESSED AND HEALED."

  Patient problems: Discomfort; Pain

  MAUDE report 21993218 ↗
• InjuryFeb 28, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "IMPLANT FAILURE OF GAMMA4. PATIENT IS 83M WHO HAD GAMMA4 IMPLANTED ON (B)(6) 2024. 6 WEEKS POST OP, HAD PAIN AT SITE. REPORTEDLY NO TRAUMATIC EPISODE/FALL FROM PATIENT. NAIL HAS BROKEN AT LAG SCREW/NAIL INTERFACE. SURGEON SUGGESTS IT IS FROM IMPLANT FAILURE. SURGEON REMOVED AND REVISED CASE TO SYNTHES DHS.".

  Patient problems: Pain

  MAUDE report 21497078 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CASE FOR AN INTERTROCHANTERIC FRACTURE, THE NAIL ATTACHED TO THE TARGETER WAS IMPACTED USING THE APPROPRIATE IMPACTOR. AFTER CONFIRMING THE POSITIONING VIA X-RAYS, IT WAS OBSERVED THAT THE TARGETER AND NAIL HAD SEPARATED. THE SURGICAL TEAM REMOVED THE TARGETER AND HARDWARE AND PROCEEDED WITH A DIFFERENT IMPLANT SYSTEM (GAMMA 3 INSTEAD OF GAMMA 4). THE SURGERY WAS COMPLETED , WITH NO ADVERSE PATIENT CONSEQUENCES OR NEED FOR MEDICAL INTERVENTION, THOUGH THERE WAS A SLIGHT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510610 ↗