GAMMA 8160-0100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327510997), received between Mar 5, 2025 and Mar 30, 2026 — classified as 6 injuries.

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

• InjuryMar 30, 2026Migration

  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 24735739 ↗
• InjuryFeb 6, 2026Migration

  IT WAS REPORTED THAT, DURING A POST-OPERATIVE CHECK-UP, MEDIALIZATION OF THE SHS WAS DETECTED. THE REVISION SURGERY WAS PERFORMED WITH G4 U-BLADE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24277868 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) STRYKER PEGASUS STUDY. NON-UNION (NO BONE CONSOLIDATION WITHIN 6 MONTHS) 6 MONTH VISIT; CT (B)(6) 2025; X-RAYS (B)(6) 2025. UPDATE DURING VISIT ON SITE: THE SITE WILL BE UPDATING THE TERM FROM NONUNION TO ¿DELAYED HEALING.¿ BONE CONSOLIDATION EVENTUALLY WAS ACHIEVED AS NOTED ON THE 12 MONTH VISIT ON (B)(6) 2025.

  Patient problems: Impaired Healing

  MAUDE report 23603092 ↗
• InjuryOct 20, 2025Migration; Migration

  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. RE-REVISION SURGERY PLANNED FOR (B)(6) 2025." THIS COMPLAINT CAPTURES THE 2ND PLANNED REVISION.

  Patient problems: Perforation

  MAUDE report 23342886 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED BY THE CUSTOMER THAT A GAMMA4 LAG SCREW BACKED OUT DURING PROCEDURE. POSTOPERATIVELY THE LAG SCREW WAS SEEN BACKED OUT OF THE NAIL. REVISION OF GAMMA NAIL WAS NECESSARY DUE TO FAILED FIXATION.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 21701322 ↗
• InjuryMar 5, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO A BROKEN LAG SCREW.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21526552 ↗