GAMMA 8160-0110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327511055), received between Apr 29, 2024 and Apr 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT: "DURING AN OPERATION ON (B)(6) 2025, THE SURGEON ENCOUNTERED A FEW DIFFICULTIES WHEN FITTING THE NAIL REF. (B)(4). APPARENTLY, THE CEPHALIC SCREW DID NOT FIT INTO THE NAIL." "MINI-ABUTMENT OF A VERY COMPLEX EPIPHYSEAL-DIAPHYSEAL FRACTURE. COMPLEX EPIPHYSEAL-DIAPHYSEAL FRACTURE. OPENING OF THE FASCIA LATA. DRILLING OF THE GREATER TROCHANTER. PLACEMENT OF REAMING GUIDE NAIL. REAMING TO DIAMETER 13 DIAPHYSEAL AND 14 METAPHYSEAL. PLACEMENT OF A NAIL DIAMETER 10, 125° CERVICAL ANGULATION, 240 LENGTH. PLACEMENT OF THE CERVICAL GUIDE PIN, WHICH WILL BE CHECKED FROM FRONT AND SIDE. CERVICAL REAMING. MEASURE LENGTH BACK TO 110. PLACE CERVICAL SCREW LENGTH 110 WHICH WILL BE LOCKED. PLACE DISTAL SCREW LENGTH TO 37.5. SCOPIC CHECK: TECHNICAL INCIDENCE, GIVEN THE ECCENTRICITY OF THE CERVICAL SCREW TO THE NAIL. ATTEMPT TO REDUCE THE OSTEOSYNTHESIS USING THE SAME MATERIAL WAS UNSUCCESSFUL. PATIENT'S CURRENT CONDITION: LONGER OPERATING TIME (60 MIN). ACTIONS TAKEN IN HOSPITAL TO MANAGE PATIENT: CHANGE OF EQUIPMENT AND CERCLAGE OF FRACTURE SITE. NAIL LENGTH 260, DIAMETER 10, ANGULATION 125°. PLACEMENT OF GUIDE WIRE, CHECKED FROM FRONT AND SIDE. BORE LENGTH 110. LOCKED 110 SCRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858197 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROUGH A CLINICAL STUDY IT WAS REPORTED THAT: "DEEP VEIN THROMBOSIS CHRONIC, RECURRENT DVTS IN PROXIMAL VEINS OF BOTH LOWER EXTREMITIES. HISTORY OF DVT EPISODES PRECEDES GAMMA-4 SURGERY DATE. ACTION TAKEN: YES. MEDICATION TREATMENT: INR 1.7, ON COUMADIN WITH FILTER. NO INDICATION FOR HOSPITALIZATION."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19201948 ↗