GAMMA4 - RC LAG SCREW D10.5X85MM
Report
- Report Number
- 0008031020-2025-01292
- Event Type
- Malfunction
- Date Received
- July 22, 2025
- Date of Event
- June 23, 2025
- Report Date
- November 12, 2025
- Manufacturer
- STRYKER GMBH
- Product Code
- HSB
- UDI-DI
- 07613327591798
- PMA / PMN Number
- K230512
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ONCE THE INVESTIGATION IS COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
THE REPORTED EVENT COULD BE CONFIRMED BASED ON THE INVESTIGATION FINDINGS. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE U-BLADE LAG SCREW ASSEMBLIES WERE RECEIVED AND ONE BLADE OF BOTH THE LAG SCREW FOUND BROKEN. IN BOTH THE LAG SCREWS, IT LOOKS LIKE THE BLADE WAS MISALIGNED WITH LAG SCREW FLUTES DURING INSERTION AS INDICATED BY THE STRONG SCRATCH MARKS AROUND THE FLUTES. MISALIGNMENT COULD BE DUE TO EITHER THE LAG SCREW NOT POSITIONED PROPERLY OR DUE TO MISALIGNED INSERTION OF U-BLADE. AS FAR AS LAG SCREWS ARE CONCERNED, BOTH THE LAG SCREW GROOVES ARE NOT HAVING MARKS OF SET SCREW TIGHTENING WHICH INDICATES THAT EITHER THE LAG SCREW WAS NOT ALIGNED PERPENDICULAR TO PROXIMAL TARGETING ARM, OR AN ATTEMPT WAS NOT MADE TO FIX THE SET SCREW PRIOR TO U-BLADE INSERTION. THIS COULD BE A PROBABLE CAUSE OF THE MISALIGNMENT BETWEEN LAG SCREW AND U-BLADE. WHETHER THE U-GUIDE WAS USED DURING INSERTION OR NOT, THIS CANNOT BE CONFIRMED POST-OPERATIVELY BASED ON INSPECTION. SINCE THE U-BLADES ARE BROKEN, A FUNCTIONAL INSPECTION WITH THE COMPONENTS RECEIVED WAS NOT POSSIBLE. ALTHOUGH WE TRIED TO INSERT THE SAMPLE LAG SCREW U- BLADE INTO THE RETURNED LAG SCREW AND WE WERE ABLE TO COMPLETE THE ASSEMBLY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE EVENT WAS CAUSED BY AN INADEQUATE ALIGNMENT BETWEEN LAG SCREW AND AND U-BLADE DURING INSERTION DUE TO WHICH IT DEVIATED FROM ITS IDEAL PATH AND ON APPLICATION OF EXCESS FORCES THE U-BLADE BROKE. IN RELATION TO THE CORRECT RC LAG SCREW ALIGNMENT AFTER INSERTION FOLLOWING STATEMENT FROM THE GAMMA4 HIP FRACTURE NAILING SYSTEM OPERATIVE TECHNIQUE (G4-ST-2, REV. 1, 11-2024) CAN BE POINTED OUT: ¿THE DESIGN OF THE RC LAG SCREW PROVIDES TWO SET SCREW GROOVES (STANDARD LAG SCREW PROVIDES FOUR). FOR CORRECT RC LAG SCREW ALIGNMENT, THE HANDLE OF THE LAG SCREWDRIVER MUST BE PERPENDICULAR TO THE PROXIMAL TARGETING ARM. THE U-BLADE LASER MARKINGS AT THE SET SCREW GROOVE INDICATORS MUST POINT TOWARDS CAUDAL AND CRANIAL INDICATING THE ORIENTATION OF THE U-BLADE IN-SITU. INSERT THE SET SCREW (REFER TO SECTION ¿SET SCREW FIXATION¿) BEFORE INSERTION OF THE U-BLADE." IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.
AS REPORTED: "ORIF FOR LEFT FEMORAL FRACTURE. STRYKER SALEREP DID NOT PARTICIPATE IN THE SURGERY BUT WAS CONTACTED BY THE SURGEON AFTER THE PROCEDURE. DURING SURGERY, AN 85 MM U-LUG SCREW WAS SELECTED, BUT WHEN ATTEMPTING TO INSERT THE U-BLADE, IT DID NOT GO IN COMPLETELY. X-RAY CONFIRMATION REVEALED THAT THE BLADE WAS BROKEN. THE SURGEON REMOVED THE BROKEN PIECE FROM THE BODY. THE SCREW WAS CHANGED TO A 90MM SCREW AND IMPLANTED. THE BLADE COULD BE INSERTED, BUT THE U-LAG SCREW CAP DID NOT FIT. THE SURGEON REMOVED THE BLADE FOR INSPECTION AND FOUND IT DEFORMED INWARD. THE SURGEON ABANDONED THE ATTEMPT TO INSERT THE U-LAG SCREW AND INSTEAD INSERTED A STANDARD 85MM LAG SCREW, CONCLUDING THE PROCEDURE. ACCORDING TO THE NURSE, SHE DOES NOT RECALL USING THE GAMMA 4U GUIDE (14203010) DURING THE PROCEDURE. SHE BELIEVES THAT THE BLADE WAS ATTACHED TO THE GAMMA 4 INSERTER (14203020) WITHOUT THE U GUIDE AND INSERTED INTO THE LAG SCREW WITHOUT THE U GUIDE. UPDATE ON JUNE 27, 2025: 88-YEAR-OLD FEMALE, BONE QUALITY: FRAGILE. IN THE PREVIOUS REPORT, THE NURSE SAID THAT SHE DID NOT REMEMBER PUTTING ON THE GAMMA 4 U-GUIDE, BUT THE DOCTOR SAID THAT SHE DID INDEED PUT ON THE U-GUIDE AND CONFIRMED THE PROCEDURE WITH OTHER DOCTORS, SO THE PROCEDURE WAS FINE. THE 85MM BLADE THAT WAS INSERTED FIRST WAS ONLY HALFWAY IN, AND SURGEON CONFIRMED THAT THE ANTERIOR AND POSTERIOR BLADES WERE CLEARLY VISIBLE IN THE IMAGE VIEW, AND WHEN THE BLADE WAS REMOVED, THE DISTAL PART OF THE U-BLADE (DISTAL TO THE LUG) WAS BURIED IN THE BONE AND I FELT IT CAUGHT ON THE CORTICAL BONE. THE BLADE DID NOT BREAK OFF IN THE BONE BUT BROKE OFF WHEN IT CAUGHT ON THE DISTAL CORTICAL BONE WHEN IT WAS PULLED OUT. THE RESIZED 90MM WAS SEEN IN THE IMAGE LATERAL VIEW TO CONFIRM THAT THE BLADE WENT ALL THE WAY IN, THE U-LUG END CAP DID NOT. THERE WAS A POSSIBILITY THAT SOFT TISSUE OR BONE DEBRIS WAS INTERFERING IN BETWEEN, SO I LOOKED DIRECTLY THROUGH THE SKIN INCISION AND COULD NOT SEE ANY SOFT TISSUE OR BONE DEBRIS. THE 90MM CAP WAS INSERTED, BUT THE DISTAL SIDE OF THE LUG MAY HAVE BEEN BURIED IN THE BONE. THE 90MM CAP ALSO DID NOT FIT, SO I REMOVED IT, BUT AS WITH THE 85MM, I FELT IT CATCH ON THE CORTICAL BONE ON THE DISTAL SIDE, WHERE THE BLADE BROKE OFF. HE ASKED US TO INVESTIGATE THE CAUSE OF THE BREAKAGE. THIS RECORD COVERS THE BREAKAGE."
AS REPORTED: "ORIF FOR LEFT FEMORAL FRACTURE. STRYKER SALEREP DID NOT PARTICIPATE IN THE SURGERY, BUT WAS CONTACTED BY THE SURGEON AFTER THE PROCEDURE. DURING SURGERY, AN 85 MM U-LUG SCREW WAS SELECTED, BUT WHEN ATTEMPTING TO INSERT THE U-BLADE, IT DID NOT GO IN COMPLETELY. X-RAY CONFIRMATION REVEALED THAT THE BLADE WAS BROKEN. THE SURGEON REMOVED THE BROKEN PIECE FROM THE BODY. THE SCREW WAS CHANGED TO A 90MM SCREW AND IMPLANTED. THE BLADE COULD BE INSERTED, BUT THE U-LAG SCREW CAP DID NOT FIT. THE SURGEON REMOVED THE BLADE FOR INSPECTION AND FOUND IT DEFORMED INWARD. THE SURGEON ABANDONED THE ATTEMPT TO INSERT THE U-LAG SCREW AND INSTEAD INSERTED A STANDARD 85MM LAG SCREW, CONCLUDING THE PROCEDURE. ACCORDING TO THE NURSE, SHE DOES NOT RECALL USING THE GAMMA 4U GUIDE (14203010) DURING THE PROCEDURE. SHE BELIEVES THAT THE BLADE WAS ATTACHED TO THE GAMMA 4 INSERTER (14203020) WITHOUT THE U GUIDE AND INSERTED INTO THE LAG SCREW WITHOUT THE U GUIDE. UPDATE ON (B)(6) 2025 88-YEAR-OLD FEMALE BONE QUALITY: FRAGILE IN THE PREVIOUS REPORT, THE NURSE SAID THAT SHE DID NOT REMEMBER PUTTING ON THE GAMMA 4 U-GUIDE, BUT THE DOCTOR SAID THAT SHE DID INDEED PUT ON THE U-GUIDE AND CONFIRMED THE PROCEDURE WITH OTHER DOCTORS, SO THE PROCEDURE WAS FINE. THE 85MM BLADE THAT WAS INSERTED FIRST WAS ONLY HALFWAY IN, AND SURGEON CONFIRMED THAT THE ANTERIOR AND POSTERIOR BLADES WERE CLEARLY VISIBLE IN THE IMAGE VIEW, AND WHEN THE BLADE WAS REMOVED, THE DISTAL PART OF THE U-BLADE (DISTAL TO THE LUG) WAS BURIED IN THE BONE AND I FELT IT CAUGHT ON THE CORTICAL BONE. THE BLADE DID NOT BREAK OFF IN THE BONE, BUT BROKE OFF WHEN IT CAUGHT ON THE DISTAL CORTICAL BONE WHEN IT WAS PULLED OUT. THE RESIZED 90MM WAS SEEN IN THE IMAGE LATERAL VIEW TO CONFIRM THAT THE BLADE WENT ALL THE WAY IN, THE U-LUG END CAP DID NOT. THERE WAS A POSSIBILITY THAT SOFT TISSUE OR BONE DEBRIS WAS INTERFERING IN BETWEEN, SO I LOOKED DIRECTLY THROUGH THE SKIN INCISION AND COULD NOT SEE ANY SOFT TISSUE OR BONE DEBRIS. THE 90MM CAP WAS INSERTED, BUT THE DISTAL SIDE OF THE LUG MAY HAVE BEEN BURIED IN THE BONE. THE 90MM CAP ALSO DID NOT FIT, SO I REMOVED IT, BUT AS WITH THE 85MM, I FELT IT CATCH ON THE CORTICAL BONE ON THE DISTAL SIDE, WHERE THE BLADE BROKE OFF. HE ASKED US TO INVESTIGATE THE CAUSE OF THE BREAKAGE. THIS RECORD COVERS THE BREAKAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490550 | GAMMA4 - RC LAG SCREW D10.5X85MM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | STRYKER GMBH | K10E745 | 07613327591798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |