GAMMA 8004-0005SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327510973), received between Jun 11, 2024 and Apr 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS IDENTIFIED ON POSTOPERATIVE FOLLOW-UP X-RAYS THAT THE END CAP HAD LOOSENED AND COME OFF THE NAIL. THE PHYSICIAN DECIDED NOT TO TAKE ANY ACTION FOR THIS EVENT, AS THE PATIENT HAS NO SYMPTOMS AND THERE IS NO ABNORMAL FRACTURE HEALING PROCESS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922145 ↗
• MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE DEVICE WAS IMPLANTED IN ORIF FOR LEFT FEMORAL TROCHANTERIC FRACTURE. THERE WAS NO PROBLEM UNTIL 3 MONTHS AFTER THE SURGERY. WHEN THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2025, IT WAS FOUND THAT THE END CAP HAD DISLODGED ABOUT +5MM. THE DOCTOR DECIDED TO PERFORM ONLY FOLLOW-UP MONITORING AS IT WOULD NOT AFFECT BONE HEALING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440276 ↗
• MalfunctionDec 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: ORIF WAS PERFORMED ON (B)(6) 2024 FOR A PATIENT WITH LEFT FEMORAL TROCHANTERIC FRACTURE. THE SURGEON INQUIRED ABOUT THE CAUSE OF LOOSENING OF THE GAMMA 4 END CAP (5 MM) POSTOPERATIVELY. THERE IS NOT ENDCAP REMOVAL/DISLOCATION BUT ONLY LOOSENESS AND THE IMPLANT DEVICES WORKS WITHOUT PLOBLEM, SO NOTHING WILL BE PERFORMED FOR THIS EVENT. BECAUSE THE END CAP IS IMPLANTED IN THE PATIENT'S BODY, NO PRODUCT IS RETURNED FROM THE FACILITY. INSTEAD, THE X-RAY IMAGE WILL BE PROVIDED AND THE DOCTOR REQUESTS STRYKER TO INSPECT THE X-RAY AND SHOW POSSIBLE CAUSE OF THE LOOSENING OF THE END CAP.

  Patient problems: Insufficient Information

  MAUDE report 20995740 ↗
• MalfunctionJul 26, 2024Positioning Failure; Positioning Failure

  AS REPORTED: THE 5 MM END CAP DID NOT FIT WELL, SO A 0 MM END CAP WAS USED AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839597 ↗
• MalfunctionJun 24, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "THE GAMMA4 END CAP 0MM COULD NOT BE INSERTED INTO THE NAIL. TRIED INSERTING ANOTHER 0MM END CAP, +5MM END CAP, BUT THEY ALSO COULD NOT BE INSERTED. FINALLY, THE SURGERY WAS COMPLETED BY IMPLANTING THE NAIL WITHOUT THE END CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594939 ↗
• MalfunctionJun 11, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "DURING THE END CAP PROCEDURE STEP, THE END CAP DID NOT FIT PROPERLY INTO THE NAIL. AT FIRST A +10MM PLUG WAS USED AND DID NOT FIT THE NAIL, AND THE +10MM PLUG WAS REPLACED WITH A +5MM PLUG BECAUSE THE THREADS OF THE +10MM PLUG MIGHT BE THE CAUSE, BUT THE +5MM PLUG DID NOT FIT THE NAIL EITHER. IN THE END, THE SURGERY WAS COMPLETED WITHOUT END CAPS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513222 ↗