GAMMA 8160-0090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327510928), received between Jun 21, 2023 and Jul 10, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Migration

  THE FOLLOWING INFORMATION WAS REPORTED: MEDIAL MIGRATING OF THE LAG SCREW WITHING GAMMA4 INTERMEDIATE NAIL.

  Patient problems: Insufficient Information

  MAUDE report 25782333 ↗
• MalfunctionFeb 6, 2026Positioning Failure

  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 24277549 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS. SUBJECT: (B)(6). ONSET DATE: (B)(6): PAIN. PATIENT FIRST LEFT MESSAGE WITH INTERNAL MEDICINE ABOUT PAINFUL LEFT HIP ON (B)(6) 2025. SHE WAS SEEN BY THE SURGEON ON (B)(6) 2025. SHE DESCRIBED DIFFUSE LEFT HIP PAIN RADIATING DOWN LEG AND WORSENED BY WEIGHTBEARING. ASSESSMENT AT (B)(6) (B)(6) 2025 FOLLOW-UP INCLUDED GT BURSITIS, ARTHRITIS, AND LEFT SI JOINT PAIN. SHE HAS TRIED GABAPENTIN AND GOT CORTISONE INJECTION AT THIS FOLLOW-UP. SHE IS CONSIDERING HIP REPLACEMENT SURGERY."

  Patient problems: Arthritis; Bursitis; Implant Pain

  MAUDE report 21806084 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "A PATIENT PRESENTED WITH INCREASING PAIN AT THE HIP CONSISTENT WITH NON-UNION ON X-RAYS THE REMOVAL OF PAINFUL HARDWARE (GAMMA-4) YESTERDAY, NON-UNION BONE REPAIR AND ULTIMATELY FIXATION WITH A NON-STRYKER NAIL". ADDITIONAL INFORMATION INDICATES NAIL BREAKAGE IS PRESENT.

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

  MAUDE report 19182191 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CLINICAL STUDY PEGASUS, DEEP VEIN THROMBOSIS WAS REPORTED. PATIENT CONTACT ORTHOPAEDIC PA REGARDING SWELLING ON 17/OCT/2023 AND WENT TO ED ON (B)(6) 2023 WHERE DOPPLER REVEALED DVT OF LLE AND BAKER'S CYST. CT ANGIOGRAM ON (B)(6) 2023. PATIENT TAKING ORAL BLOOD THINNER AND FOLLOWING UP WITH VASCULAR SURGEON. DESCRIBE TREATMENT: TAKING ORAL ANTICOAGULANTS, DID CT ANGIOGRAM, SEEKING OPINIONS ON SURGICAL TREATMENT OPTION. POTENTIAL INTERVENTIONAL VASCULAR INTERVENTION.

  Patient problems: Cyst(s); Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 18521793 ↗
• InjuryJan 2, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AS REPORTED: "GAMMA4 NAIL TO FIX AN INTERTROCH FX. 4-6 WEEK POST OP XRAYS LOOKED NORMAL, AS EXPECTED. PT THEN PRESENTED TO ED 12/9, -XRAYS SHOWED LAG SCREW COMPLETELY DISENGAGED AND MEDIALIZED. PATIENT NEEDED REVISION SURGERY.

  Patient problems: Perforation

  MAUDE report 18426895 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "POSTOPERATIVE LAG SCREW CUTOUT WAS OCCURRED. A REVISION SURGERY IS PLANNED."

  Patient problems: Hip Fracture; Perforation

  MAUDE report 18138256 ↗
• InjuryJun 21, 2023Migration; Migration

  AS REPORTED: "IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THE LAG SCREW PENETRATING THROUGH THE PATIENT'S FEMORAL HEAD. THE NAIL AND ALL SCREWS WERE REMOVED AND A HEMI HIP WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON."

  Patient problems: Hip Fracture; Perforation

  MAUDE report 17172005 ↗