GAMMA 1320-0200Recalls & reported problems
Stryker GmbH · Lag Screwdriver · Class 1
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Gamma lag screwdriver is a manual orthopedic instrument used to position the cephalic screw during hip fracture surgery. Most of the 68 reports describe the tool bending, twisting, or breaking during use, with screws no longer gripping the screwdriver or prongs snapping off, and a few mention the guide wire advancing past the bone. There are 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 04546540377807), received between Jun 8, 2018 and Aug 31, 2026 — classified as 3 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (22 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation22
- Material Twisted/Bent22
- Break20
- Fracture13
- Use of Device Problem4
- Material Fragmentation3
- Defective Device2
- Device Difficult to Setup or Prepare2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Known Impact Or Consequence To Patient20
- Insufficient Information8
- Foreign Body In Patient3
- No Consequences Or Impact To Patient3
- Failure of Implant2
- No Information2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Use of Device Problem
It was reported that the device was defective.
Patient problems: Insufficient Information
MAUDE report 50525748 ↗MalfunctionJun 30, 2026Fracture
AS REPORTED: "THE PRONGS ON THE ITEM ARE COMPLETELY BROKEN OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673057 ↗MalfunctionApr 14, 2026Use of Device Problem; Material Twisted/Bent
AS REPORTED: "THE SCREWS NO LONGER STAY ON THE SCREWDRIVER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874708 ↗MalfunctionDec 18, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation
AS REPORTED: "INSTRUMENT NO LONGER ¿GRIPS¿ THE FEMORAL NECK SCREW."
Patient problems: Insufficient Information
MAUDE report 23839713 ↗MalfunctionSep 19, 2025Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent
IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 23098167 ↗MalfunctionSep 15, 2025Material Twisted/Bent; Material Twisted/Bent
AS REPORTED: "SCREWDRIVER SIGNIFICANTLY BENT, NO LONGER USABLE.''
Patient problems: Insufficient Information
MAUDE report 23053519 ↗MalfunctionMay 5, 2025Material Deformation; Material Twisted/Bent; Insufficient Device Problem Information; Material Deformation; Material Twisted/Bent; Insufficient Device Problem Information
AS REPORTED: "DEFECTIVE FEMORAL NECK SCREWDRIVER."
Patient problems: Insufficient Information
MAUDE report 21960320 ↗MalfunctionNov 19, 2024Material Deformation; Damaged Thread; Material Deformation; Damaged Thread
DURING NAIL EXTRACTION OF A LONG GAMMA NAIL, THE CONNECTION PART (INNER ROD) OF THE LAG SCREW DRIVER WAS DEFORMED. THE DEFORMATION WAS CAUSED BY THE SURGEON'S LARGE MOVEMENT OF THE SCREWDRIVER AFTER CONNECTING THE LAG SCREWDRIVER TO THE LAG SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20730625 ↗MalfunctionMay 14, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
AS REPORTED: "THE THREAD OF THE G3 THIGH NECK SCREWDRIVER 1320-0200 BENT WHEN SCREWING IN THE G3 THIGH NECK SCREW 3060-0095S. THREAD MUST NOT ACTUALLY BEND. NO OBSTACLE INTRAOPERATIVELY. SCREWING IN THE SCREW WAS EASY, BUT THE THREAD WAS STILL BENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19308582 ↗MalfunctionMay 7, 2024Break; Fracture; Off-Label Use; Material Deformation; Material Twisted/Bent; Break; Fracture; Off-Label Use; Material Deformation; Material Twisted/Bent
AS REPORTED: "THE THREAD OF THE GAMMA3 FEMORAL NECK SCREWDRIVER 1320-0200 HAS BENT WHEN REMOVING THE FEMORAL NECK SCREW 3060-0095S. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19264370 ↗MalfunctionFeb 21, 2024Material Deformation; Material Deformation
AS REPORTED: "LAG SCREW COULD NOT BE TIGHTEN PROPERLY DUE TO POSSIBLE DAMAGE OF THE TIP OF THE LAG SCREW DRIVER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18749174 ↗MalfunctionFeb 15, 2024Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation
AS REPORTED: "FEMORAL NECK SCREW CAN NO LONGER BE PROPERLY TIGHTENED BY THE INSTRUMENT. THREAD DOES NOT ENGAGE. REPLACEMENT WAS AVAILABLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18717588 ↗MalfunctionNov 16, 2023Break; Fracture; Break; Fracture
AS REPORTED: "LAG SCREW DRIVER WAS BROKEN."
Patient problems: Insufficient Information
MAUDE report 18147176 ↗MalfunctionAug 31, 2023Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
AS REPORTED: "THE CONNECTION BETWEEN THE LAG SCREW DRIVER AND THE LAG SCREW WAS NOT PROPERLY MADE, LEADING DIFFICULTY IN REMOVING THE LAG SCREW. THE DOCTOR TOLD THAT HE FELT THE THREAD PART AT THE TIP OF THE LAG SCREW DRIVER WAS STRIPPED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667619 ↗MalfunctionJul 12, 2023Break; Fracture; Material Deformation; Break; Fracture; Material Deformation
AS REPORTED: "DURING A NAIL REMOVAL, THE SCREWDRIVER TIP DEFORMED. THE PATIENT HAD IMPLANTS 20 YEARS AGO AND THE BONE APPEARED TO BE HARD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305414 ↗MalfunctionMar 23, 2023Material Deformation; Material Deformation
AS REPORTED: "DURING A CASE AT ELLIS HOSPITAL IN SCHENECTADY NY, THE TOP WHEEL OF THE LAG SCREW C-HANDLE SEEMED TO HAVE A LITTLE INDENTATION. SURGERY WAS COMPLETED WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16604398 ↗MalfunctionFeb 23, 2023Break; Fracture; Material Fragmentation; Unraveled Material; Break; Fracture; Material Fragmentation; Unraveled Material
AS REPORTED: "SPIKES ON SCREWDRIVER BROKEN OFF AT FRONT, THREAD LOOSE ON WIRE." THERE WAS A 60 MINUTE SURGICAL DELAY. ALL DEBRIS WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16426613 ↗MalfunctionFeb 23, 2023Break; Fracture; Material Fragmentation; Unraveled Material; Break; Fracture; Material Fragmentation; Unraveled Material
AS REPORTED: "SPIKES ON SCREWDRIVER BROKEN OFF AT FRONT, THREAD LOOSE ON WIRE." THERE WAS A 60 MINUTE SURGICAL DELAY. ALL DEBRIS WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16426606 ↗MalfunctionDec 26, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS A BENT SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16048829 ↗MalfunctionOct 2, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT ONE OF THE TEETH AT THE END OF THE LAG SCREWDRIVER CAME OFF DURING THE PROCEDURE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 15526176 ↗MalfunctionJul 22, 2022Material Twisted/Bent; Material Twisted/Bent
AS REPORTED: "THREAD OF THE INNER PART OF THE G3 THIGH NECK SCREWDRIVER FOR FIXING THE SCREW IS BENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15083613 ↗MalfunctionJun 3, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE TEETH ARE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14591690 ↗MalfunctionJun 3, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE TEETH ARE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14591683 ↗MalfunctionMay 23, 2022Material Deformation; Material Deformation
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE INNER CORE THREAD OF THE CEPHALIC SCREWDRIVER WAS EATEN FOR THE FIRST FEW THREADS, SO IT COULD NOT SCREW ONTO THE CEPHALIC SCREW." ADDITIONAL INFORMATION: NO DEBRIS REPORTED. THE DEVICE WAS ALREADY BROKEN WHEN ARRIVED. THERE WAS A 20 MINUTE DELAY TO THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14476876 ↗InjuryMay 20, 2022Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation
IT WAS REPORTED THAT THE GAMMA LAG SCREW WAS BEING REVISED, DUE TO PATIENT DISCOMFORT, AND THE SURGEON WAS UNABLE TO THREAD THE INNER CONNECTING PIECE ONTO THE LAG SCREW ITSELF. A PEEL PACK WAS AVAILABLE WAS USED INSTEAD. EVERYTHING WAS ABLE TO ATTACH AFTERWARDS. UPON INSPECTION OF THE INSTRUMENT IN QUESTION, IT WAS NOTICED THAT THE THREADS WERE DAMAGED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 14461556 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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