GAMMA 3130-1180SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540375124), received between Mar 3, 2016 and Mar 24, 2026 — classified as 19 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALES REP THAT THE PATIENT THAT WAS IMPLANTED IN 2012 NEED TO DO A REVISION SURGERY DUE TO THE INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 24682130 ↗
• MalfunctionDec 18, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE TARGET DEVICE CANNOT BE DETACHED FROM THE IMPLANT. THE NAIL WAS COMPLETELY IMPLANTED, INCLUDING PROXIMAL AND DISTAL LOCKING. THE TARGET BAR COULD NO LONGER BE DISCONNECTED VIA THE NAIL RETAINING SCREW, SO AN ATTEMPT WAS MADE TO REMOVE THE DISTAL LOCKING. HOWEVER, THE TARGET BAR WAS IN THE WAY, SO AN ATTEMPT WAS MADE TO SHORTEN IT USING A SAW. ULTIMATELY, THE BAR AND NAIL WERE REMOVED USING A HAMMER. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839381 ↗
• MalfunctionJun 10, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "FRACTURE OF AN IMPLANTED GAMMA NAIL, METAL REMOVAL, THE ISSUE WAS NOTICED BY THE PAINFUL FULL WEIGHT BEARING OF THE PATIENT AND BY THE XRAY IMAGES. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, THE FIRST SURGERY WAS PERFORMED ON (B)(6) 2024, PATIENT'S ACTIVITY LEVEL AFTER IMPLANTATION-FULLY LOADED, PAINFUL. ''

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

  MAUDE report 22175431 ↗
• InjuryMay 23, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "FAILED SHORT GAMMA NAIL. THE SURGEON IDENTIFIED CONCERN AT 8 WEEK POST OPERATION. NAIL IS BROKEN AT THE PROXIMAL END OF THE NAIL / LAG SCREW JUNCTION. ISSUE NOTICED: POST OPERATIVE 8 WEEKS. RETROSPECTIVELY UPON FURTHER INVESTIGATION BY CONSULTANT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078119 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, IT WAS NOTED THAT OSTEOSYNTHESIS WAS NOT POSSIBLE TO BE PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 19938829 ↗
• InjuryApr 11, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "I'M IN PETERBOROUGH HOSPITAL, THEY HAVE A GAMMA NAIL WHERE THE LAG SCREW HAS MIGRATED INTO THE PELVIS. THE EXTRACTION IS TODAY. "

  Patient problems: Failure of Implant; Perforation

  MAUDE report 19086038 ↗
• InjuryMar 7, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "PATHOLOGICAL LATERAL FEMORAL NECK FRACTURE IN THE SENSE OF AN INSUFFICIENCY FRACTURE DUE TO OBESITY IN THE ABSENCE OF TRAUMA, GAMMA NAIL SURGERY (B)(6) 2022 TOOK PLACE. IN THE COURSE OF TILTING / VARIZATION OF THE FEMORAL NECK / FEMORAL HEAD AND PSEUDARTHROSIS. CT IMAGING OF THE NAIL FRACTURE IN THE AREA OF THE FEMORAL NECK SCREW. INDICATION FOR MATERIAL REMOVAL AND CEMENTLESS RIGHT HIP TEP. SURGERY ON (B)(6) 2024 WAS PERFORMED."

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

  MAUDE report 18861716 ↗
• MalfunctionJan 10, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "A NECK OF FEMUR FRACTURE WAS TO BE TREATED WITH A GAMMA SHORT NAIL. DURING THE PROCEDURE AN ISSUE AROSE INSERTING THE SET SCREW. DETAILS ARE UNCLEAR BUT DIFFICULTY CAUSED THEM TO REMOVE THE SET SCREW AND OPEN A SPARE. CASE WAS THEN COMPLETED WITHOUT FURTHER ISSUES THAT WERE RAISED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482768 ↗
• InjuryJan 8, 2024Positioning Failure; Positioning Failure

  AS REPORTED BY REP: PATIENT: (B)(6) FEMALE PRESENTING WITH RIGHT INTERTROCHANTERIC FRACTURE BEING TREATED WITH A GAMMA 3 SHORT NAIL. INCIDENT REPORT: PROCEDURE BEGAN AND FOLLOWED OPERATIVE TECHNIQUE PROTOCOL, ENTRY MADE USING CURVED AWL, INSERTED A K-WIRE THROUGH THE CANNULATION & PREPARED PROXIMAL FEMUR WITH REAMER. NAIL WAS SELECTED, CONNECTED TO TARGETING JIG AND CALIBRATION CHECK WAS CONFIRMED USING THE STEP DRILL. NAIL WAS INSERTED TO DESIRED DEPTH AND K-WIRE INSERTED INTO FEMUR HEAD AS-PER OPERATIVE TECHNIQUE. MEASURED 90MM, CONSULTANT INFORMED THIS WOULD BE TO BASE OF K-WIRE THREADS. DECISION WAS MADE TO INCREASE TO 95MM. FEMUR WAS DRILLED TO PREPARE FOR LAG SCREW AND LAG SCREW INSERTED TO DESIRED DEPTH. HOWEVER, ISSUE AROSE WITH SET SCREW. SET SCREW WAS CONNECTED TO SET SCREWDRIVER, CLOSED LOOP CLIP CONNECTED TO JIG AND THEN SET SCREW INSERTED. CONSULTANT WAS INSTRUCTED TO ¿WIGGLE¿ THE SCREWDRIVER BEFORE ENGAGING THREADS, SEEKING FOR THE NOTABLE DROP TO THE START OF THE THREADS. SET SCREW WAS THEN ADVANCED BY TURNING THE SCREWDRIVER CLOCKWISE, AFTER A FEW TURNS IT BECAME APPARENT SIGNIFICANT RESISTANCE WAS BEING ENCOUNTERED AND AN AUDIBLE SQUEAKING WAS HEARD. I INSTRUCTED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469671 ↗
• MalfunctionFeb 23, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE END USER REPORTED THAT GAMMA3 NAIL CAN NO LONGER BE DISCONNECTED FROM THE NAIL HOLDING SCREW AND THE AIMING DEVICE." THE NAIL HAD TO BE COMPLETELY REMOVED FROM THE TARGET DEVICE SO THEY TRIED FOR A SIGNIFICANT AMOUNT OF TIME TO DO SO AND AFTERWARDS A NEW IMPLANT HAD TO BE PLACED FREEHAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428196 ↗
• InjuryDec 28, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA3 NAIL BROKE TWO MONTHS AFTER IMPLANTATION AND HAD TO BE REMOVED AGAIN. THE PATIENT HAD TO UNDERGO A SECOND SURGERY, DURING WHICH THE BROKEN GAMMA NAIL HAD TO BE REMOVED AND A NEW NAIL INSERTED".

  Patient problems: Failure of Implant

  MAUDE report 16060774 ↗
• InjuryFeb 3, 2022Break; Break

  THE CUSTOMER REPORTED A BROKEN NAIL WHICH REQUIRED REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 13446817 ↗
• InjuryOct 12, 2021Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH MW5103685 THAT A SHORT TROCH NAIL REQUIRED A REVISION A YEAR POSTOPERATIVELY (ORIGINAL SURGERY 2020). THE TOP OF THE TROCH NAIL BROKE OFF AND THE LAG SCREW THROUGH THE NAIL BROKE. UPDATE-10/28/2021. HIP STARTED HURTING & PRESENTED FOR APPT BECAUSE OF SHARP HIP PAIN ON (B)(6) 2021. REQUIRED SURGICAL PROCEDURE TO REMOVE BROKEN IMPLANTS. IMPLANTS WERE USED FOR AN OPEN REDUCTION INTERNAL FIXATION RIGHT HIP FRACTURE. UNABLE TO PROVIDE X-RAYS AND MEDICAL RECORDS WITHOUT PATIENT'S CONSENT. WALKER WHEN UP, 50% WEIGHT BEARING. AMBULATES WITH WALKER, LIVED INDEPENDENTLY PRIOR TO SURGERY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12615562 ↗
• InjuryDec 26, 2019Migration; Migration

  IT WAS REPORTED, THE G3 FEMORAL NECK SCREW HAS MIGRATED THROUGH THE NAIL INTO THE PATIENT'S PELVIS AFTER GAMMA 3 SURGERY. ACCORDING TO THE SURGEON, THEY EXACTLY USED THE OPERATION DESCRIPTION AND ALSO THE LOCKING BOLT WAS CORRECTLY LOCKED IN THE GROOVES OF THE SCREW. PATIENT HAD TO BE OPERATED AGAIN, GOT A FEMUR REPLACEMENT.

  Patient problems: Injury

  MAUDE report 9520025 ↗
• InjuryOct 30, 2019Failure to Osseointegrate; Appropriate Device Problem Term/Code Not Available; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO FAILED FIXATION OF THE SHORT GAMMA NAIL. PATIENT WAS REVISED TO A STRYKER HEMI HIP CONSTRUCT. REP REPORTED THAT HE CAN PROVIDE AN X-RAY AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; No Code Available

  MAUDE report 9258556 ↗
• MalfunctionNov 15, 2018Device Markings/Labelling Problem

  THE HOSPITAL REPORTED THE FOLLOWING EVENT : "THE ORTHOPAEDIC INTERN REQUIRES A 130° SHORT NAIL. THE CIRCULATING IBODE CHECKS THE IMPLANT, HAS IT CHECKED BY THE INSTRUMENT IBO. AFTER VERIFICATION, THE IBODE STICKS THE LABELS AND REALIZES THAT SOMETHING IS WRONG. INDEED, SHE SEES THAT THE 130° NAIL WAS A 125° NAIL LABELLED AND IN A 130° NAIL PACKAGE. CLINICAL CONSEQUENCES NOTED: NONE . PRECAUTIONARY MEASURES AND ACTIONS TAKEN: IMPLANT CHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075478 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELE AFTER HIP FRACTURE. THE 219 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7780397 ↗
• InjuryAug 14, 2018Fracture

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELE AFTER HIP FRACTURE. THE 173 OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

  Patient problems: Hip Fracture

  MAUDE report 7780131 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY (GIRDLESTONE) DUE TO DEEP INFECTION. THE 61 OUT OF 290 CASES.

  Patient problems: Unspecified Infection

  MAUDE report 7778929 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELAE AFTER HIP FRACTURE. CASE 81 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7771610 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELAE AFTER HIP FRACTURE. CASE 70 OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

  Patient problems: Bone Fracture(s); Death

  MAUDE report 7771604 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY (RE-OSTESYNTHESIS) DUE TO UNKNOWN REASON. TWENTY-SIX OUT OF 290 CASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7771599 ↗
• InjuryAug 7, 2018Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELAE AFTER HIP FRACTURE. CASE 9 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7756997 ↗
• InjuryMar 3, 2016Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THERE IS NO BROKEN NAIL AS PER ATTACHED X-RAYS, BUT OSTEOSYNTHESIS ITSELF FAILED, SO REVISION SURGERY IS REQUIRED. THE SURGEON STATED THAT "OUR OPINION WHY IMPLANT FAILED IS INAPPROPRIATE REPOSITION, WE DID NOT RESTORE ADAMS ARCH. THERE IS VISIBLE MEDIAL MOVEMENT OF ALL IMPLANT DUE TO LAXITY IN DIAFYSAL BOLE. DYNAMIC FIXATION WAS USED. IF ONLY STEM OF THE NAIL WAS BIGGER - E.G. 13MM OR OF THERE IS A STOP ON THE END OF HIP SCREW - IT WOULD PREVENT MEDIAL DISLOCATION OF NAIL.

  Patient problems: No Information

  MAUDE report 5475945 ↗