GAMMA 1320-0233Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04546540592545), received between Aug 27, 2015 and Feb 26, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (8 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fracture; Detachment of Device or Device Component

  AS REPORTED: "THE RING ON THE TIP OF THE SET SCREWDRIVER BROKE DURING SET SCREW TIGHTENING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454446 ↗
• MalfunctionNov 22, 2022Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  IT WAS REPORTED THAT, "FLEXIBLE SCREWDRIVER 1320-0233 (STRYKER BRAND) PRESENT IN THE GAMMA CLOU BOXES WHOSE DESIGN DOES NOT ALLOW EITHER: - CLEAN IT PROPERLY - CONTROL ITS CLEANLINESS DURING RE-COMPOSITION. DESPITE THE TRAINING OF OPERATORS IN CLEANING AND THE SCRUPULOUS HUMAN CONTROLS CARRIED OUT DURING RECOMPOSITION (THIS BOX WAS RECOMPOSED BY A NURSE WHO WAS WELL AWARE OF THE PROBLEM: SHE INDICATED THAT SHE HAD TWISTED THE SPRING TO CHECK ITS CLEANLINESS BETWEEN THE COILS AND HAD NOT DETECTED ANY RESIDUE), THIS SCREWDRIVER WAS IDENTIFIED AS DIRTY WHEN THE BOX WAS OPENED IN THE OPERATING ROOM. IT IS LIKELY THAT IT IS ORGANIC RESIDUE TRAPPED INSIDE THE SPRING AND VAPORIZED BY PRESSURIZED STEAM DURING THE AUTOCLAVE PROCESS. AS THIS UNDESIRABLE EVENT HAS BEEN A PROBLEM DURING SURGERY WITH POTENTIAL CONSEQUENCES FOR THE OPERATED PATIENT, WE HAVE ASKED STRYKER TO CARRY OUT THE NECESSARY INVESTIGATIONS AND TO PROPOSE AN ALTERNATIVE (E.G.: OLD SHEATHED MODEL?) TO THIS MODEL OF UNSHEATHED SCREWDRIVER. CURRENT STATUS OF THE PATIENT: DM ESSENTIAL FOR SURGERY AT NO OTHER BOX AVAILABLE. PATIENT UNDER SPINAL ANESTHESIA. THE SCREWDRIVER IS CLEANED WITH SALINE AND THE SOILED PART IS ISOLATED WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847691 ↗
• MalfunctionApr 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE FLEXIBLE SHAFT OF THE SCREWDRIVER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088140 ↗
• MalfunctionJan 10, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED "AS DISCUSSED THIS EVENING, THE OPERATING ROOM HAS REPORTED AN INCIDENT ENCOUNTERED ON EACH SCREWDRIVER FOR THE LOCKING SCREW (REF 1320-0233) OF OUR TWO GAMMA 3 NAIL ANCILLARIES.BLACK DEBRIS WAS FOUND ON THE COILS OF THESE TWO SCREWDRIVERS WHEN OPENING EACH OF THE BOXES.WE WONDER ABOUT THE NATURE OF THIS DEBRIS, THE HYPOTHESIS OF DRIED BLOOD INSIDE THE SPIRES BEING PREFERRED.THE STERILIZATION AGENTS BRUSHED AS MUCH AS POSSIBLE AT THE LEVEL OF THESE COILS, BUT THESE BEING VERY TIGHT, IT IS NOT POSSIBLE TO BRUSH INSIDE NOR TO ENSURE US OF THE STATE OF THE INSTRUMENT INSIDE THESE COILS.THE TWO BOXES BEING NECESSARY FOR THE NIGHT IN CASE OF EMERGENCY, AND NOT HAVING A SPARE SCREWDRIVER OR ANY OTHER ALTERNATIVE, THESE BOXES WERE RETURNED TO THE BLOCK AFTER AN IMPORTANT MANUAL BRUSHING AT THE LEVEL OF THE COILS, THEN PASSAGE OF THE WHOLE MATERIAL IN WASHER-DISINFECTOR AND IN AUTOCLAVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203883 ↗
• MalfunctionJan 10, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED "AS DISCUSSED THIS EVENING, THE OPERATING ROOM HAS REPORTED AN INCIDENT ENCOUNTERED ON EACH SCREWDRIVER FOR THE LOCKING SCREW (REF 1320-0233) OF OUR TWO GAMMA 3 NAIL ANCILLARIES. BLACK DEBRIS WAS FOUND ON THE COILS OF THESE TWO SCREWDRIVERS WHEN OPENING EACH OF THE BOXES. WE WONDER ABOUT THE NATURE OF THIS DEBRIS, THE HYPOTHESIS OF DRIED BLOOD INSIDE THE SPIRES BEING PREFERRED. THE STERILIZATION AGENTS BRUSHED AS MUCH AS POSSIBLE AT THE LEVEL OF THESE COILS, BUT THESE BEING VERY TIGHT, IT IS NOT POSSIBLE TO BRUSH INSIDE NOR TO ENSURE US OF THE STATE OF THE INSTRUMENT INSIDE THESE COILS. THE TWO BOXES BEING NECESSARY FOR THE NIGHT IN CASE OF EMERGENCY, AND NOT HAVING A SPARE SCREWDRIVER OR ANY OTHER ALTERNATIVE, THESE BOXES WERE RETURNED TO THE BLOCK AFTER AN IMPORTANT MANUAL BRUSHING AT THE LEVEL OF THE COILS, THEN PASSAGE OF THE WHOLE MATERIAL IN WASHER-DISINFECTOR AND IN AUTOCLAVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203882 ↗
• MalfunctionJan 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT : "FOR INFORMATION, WE MET AGAIN THE ISSUE WE HAD 2 OR 3 YEARS AGO ON THE GAMMA NAILS: BLACK DEBRIS ("COOKED" BLOOD?) ON THE FLEXIBLE PART OF THE SCREWDRIVER, REQUIRING THE OPENING OF A 2ND "HEALTHY" INSTRUMENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220319 ↗
• MalfunctionJan 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT : "FOR INFORMATION, WE MET AGAIN THE ISSUE WE HAD 2 OR 3 YEARS AGO ON THE GAMMA NAILS: BLACK DEBRIS ("COOKED" BLOOD?) ON THE FLEXIBLE PART OF THE SCREWDRIVER, REQUIRING THE OPENING OF A 2ND "HEALTHY" INSTRUMENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219963 ↗
• MalfunctionJan 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT : "FOR INFORMATION, WE MET AGAIN THE ISSUE WE HAD 2 OR 3 YEARS AGO ON THE GAMMA NAILS: BLACK DEBRIS ("COOKED" BLOOD) ON THE FLEXIBLE PART OF THE SCREWDRIVER, REQUIRING THE OPENING OF A 2ND "HEALTHY" INSTRUMENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219921 ↗
• MalfunctionJan 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT : "FOR INFORMATION, WE MET AGAIN THE ISSUE WE HAD 2 OR 3 YEARS AGO ON THE GAMMA NAILS: BLACK DEBRIS ("COOKED" BLOOD?) ON THE FLEXIBLE PART OF THE SCREWDRIVER, REQUIRING THE OPENING OF A 2ND "HEALTHY" INSTRUMENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219890 ↗
• MalfunctionDec 16, 2020Defective Component; Material Twisted/Bent; Defective Component; Material Twisted/Bent

  AS REPORTED: "LEFT FEMORAL TROCHANTERIC FRACTURE. THE SPRING PART OF THE SCREWDRIVER WAS DAMAGED WHILE INSERTING THE SET SCREW, AND THE SCREW COULD NOT BE FASTENED. THE SURGERY WAS COMPLETED WITH A REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016016 ↗
• MalfunctionJun 29, 2020Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  AS REPORTED: SCREWDRIVER IS STRONGLY BENT AT THE FLEXIBLE PART AND SINGLE WIRES ARE BROKEN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10208282 ↗
• MalfunctionApr 23, 2020Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "ALL THREE SIEVES / SCREWDRIVERS ARE DIRTY AFTER PREPARATION AND STERILIZATION AFTER OPENING THE SIEVE [...]. AS A RESULT, THE OPERATING ROOM STAFF HAD TO OPEN A NEW SIEVE INTRAOPERATIVELY. UNFORTUNATELY, THE INSTRUMENTS WERE ALSO DIRTY HERE. THE INSTRUMENTS WERE CLEANED BY ULTRASOUND AND IN A WATER BATH UNDER BENDING - HERE THE NOTE THAT BENDING IS PROBABLY VERY DIFFICULT. THERE WAS NO ADDITIONAL STEAM CLEANING, AS THERE IS A FEAR THAT RESIDUES MAY BE PUSHED FURTHER "INSIDE". SINCE SUCH OBVIOUS CONTAMINATION WAS NOT NOTICED DURING CLEANING (EVEN WHEN CLEANING AGAIN - THE DIRTY BUT UNUSED INSTRUMENTS HAVE BEEN REPROCESSED AGAIN), IT IS ASSUMED THAT THE "CONTAMINATION" IS "PULLED OUT" AGAIN IN THE FRACTIONATED VACUUM PROCESS. FOR THIS REASON, THE CONTAMINATION IS ONLY VISIBLE AFTER STERILIZATION AND OPENING. SALES REP MENTIONED THE ADDITIONAL CLEANING INSTRUCTIONS AGAIN IN THE CONVERSATION AND ALSO MENTIONED THE RIGID SCREWDRIVER AS AN ALTERNATIVE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9992974 ↗
• MalfunctionMar 30, 2020Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "ALL THREE SIEVES / SCREWDRIVERS ARE DIRTY AFTER PREPARATION AND STERILIZATION AFTER OPENING THE SIEVE [...]. AS A RESULT, THE OR STAFF HAD TO OPEN A NEW SIEVE INTRAOPERATIVELY. UNFORTUNATELY, THE INSTRUMENTS WERE ALSO DIRTY HERE. THE INSTRUMENTS WERE CLEANED BY ULTRASOUND AND IN A WATER BATH UNDER BENDING - HERE THE NOTE THAT BENDING IS PROBABLY VERY DIFFICULT. THERE WAS NO ADDITIONAL STEAM CLEANING, AS THERE IS A FEAR THAT RESIDUES MAY BE PUSHED FURTHER "INSIDE". SINCE SUCH OBVIOUS CONTAMINATION WAS NOT NOTICED DURING CLEANING (EVEN WHEN CLEANING AGAIN - THE DIRTY BUT UNUSED INSTRUMENTS HAVE BEEN REPROCESSED AGAIN), IT IS ASSUMED THAT THE "CONTAMINATION" IS "PULLED OUT" AGAIN IN THE FRACTIONATED VACUUM PROCESS. FOR THIS REASON, THE CONTAMINATION IS ONLY VISIBLE AFTER STERILIZATION AND OPENING. SALES REP MENTIONED THE ADDITIONAL CLEANING INSTRUCTIONS AGAIN IN THE CONVERSATION AND ALSO MENTIONED THE RIGID SCREWDRIVER AS AN ALTERNATIVE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9901489 ↗
• MalfunctionMar 30, 2020Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "ALL THREE SIEVES / SCREWDRIVERS ARE DIRTY AFTER PREPARATION AND STERILIZATION AFTER OPENING THE SIEVE [...]. AS A RESULT, THE OR STAFF HAD TO OPEN A NEW SIEVE INTRAOPERATIVELY. UNFORTUNATELY, THE INSTRUMENTS WERE ALSO DIRTY HERE. THE INSTRUMENTS WERE CLEANED BY ULTRASOUND AND IN A WATER BATH UNDER BENDING - HERE THE NOTE THAT BENDING IS PROBABLY VERY DIFFICULT. THERE WAS NO ADDITIONAL STEAM CLEANING, AS THERE IS A FEAR THAT RESIDUES MAY BE PUSHED FURTHER "INSIDE". SINCE SUCH OBVIOUS CONTAMINATION WAS NOT NOTICED DURING CLEANING (EVEN WHEN CLEANING AGAIN - THE DIRTY BUT UNUSED INSTRUMENTS HAVE BEEN REPROCESSED AGAIN), IT IS ASSUMED THAT THE "CONTAMINATION" IS "PULLED OUT" AGAIN IN THE FRACTIONATED VACUUM PROCESS. FOR THIS REASON, THE CONTAMINATION IS ONLY VISIBLE AFTER STERILIZATION AND OPENING. SALES REP MENTIONED THE ADDITIONAL CLEANING INSTRUCTIONS AGAIN IN THE CONVERSATION AND ALSO MENTIONED THE RIGID SCREWDRIVER AS AN ALTERNATIVE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9901486 ↗
• MalfunctionMar 17, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS REPORTED: "I FELT RESISTANCE WHEN INSERTING THE SET SCREW, BUT INSERTED THE SCREWDRIVER AS IT WAS. I FELT THAT I COULDN'T PROCEED WHILE TURNING THE DRIVER. ONCE THE DRIVER WAS REMOVED, THE FLEXIBLE PART WAS DAMAGED." THE PROCEDURE WAS COMPLETED USING A SET SCREWDRIVER PREPARED IN ANOTHER CASE. AFTER THE SURGERY, THE DOCTOR SAID, "THE END CAPS ARE FLOATING A LITTLE MORE THAN USUAL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9845750 ↗
• MalfunctionNov 22, 2019Component Missing; Component Missing

  IT WAS REPORTED: THE BLUE RING OF THE FLEXIBLE SCREWDRIVER IS MISSING. THE DEVICE WAS ORDERED ONE MONTH AGO. PRIOR TO THE SURGERY, IT WAS ALSO DETERMINED THAT THE LOCKING BOLT ON THE FLEXIBLE SCREWDRIVER IS NOT TIGHT ANYMORE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9365462 ↗
• MalfunctionOct 10, 2019Problem with Sterilization; Manufacturing, Packaging or Shipping Problem

  THE FOLLOWING REPORT WAS SUBMITTED BY BFARM: THE INFORMATION RECEIVED INDICATES THAT THE HOSPITAL WAS NOT SATISFIED WITH THE STERILITY OF THE DEVICE AFTER THE REPROCESSING PROCESS. THE INITIAL REPORTER INDICATED THAT THE "STRUCTURAL DESIGN OF THE MEDICAL DEVICE DOES NOT ALLOW VISUAL INSPECTION FOR RESIDUAL CONTAMINATION AFTER MACHINE CLEANING AND DISINFECTION. ANY RESIDUAL CONTAMINATION IS A DANGER TO THE PATIENT. THE MANUFACTURER CANNOT PROVIDE ANY SPECIAL PROCESSING INSTRUCTIONS FOR THIS MEDICAL DEVICE. THE GENERAL REPROCESSING INSTRUCTIONS FOR REUSABLE MEDICAL DEVICES OF THE MANUFACTURER APPLY. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9177191 ↗
• MalfunctionFeb 27, 2019Break; Difficult to Insert; Loose or Intermittent Connection

  DURING A GAMMA 3 OPERATION, WHEN INSERTING THE GRUB SCREW ON THE TARGET DEVICE. THE INSERTION OF THE GRUB SCREW WAS VERY DIFFICULT, SO THAT THE INSTRUMENT WAS PULLED OUT AND THE DEFECT WAS DETECTED. THE FLEXIBLE PIECE AT THE END OF THE INSTRUMENT IS BROKEN. THE SPIRAL SHEATH HAS LOOSENED. THE REST OF THE SURGERY WAS INCONSPICUOUS AND THE INSERTION OF THE GAMMA NAIL ALSO COMPLIED WITH THE FEMORAL NECK SCREW. A SECOND GAMMA NAIL INSTRUMENT WAS AVAILABLE. SURGICAL DELAY OF 60 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375072 ↗
• MalfunctionJan 24, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE HOSPITAL REPORTED THE FOLLOWING EVENT: "BLACK PARTICLES COMING OUT OF THE SCREWDRIVER HOSE. FIRST OBSERVATION ON (B)(6), THE STERILIZATION DEPARTMENT APPLIED A MANUAL RINSE (AFTER PRE-DISINFECTION IN THE OPERATING ROOM), BRUSHED, BLEW THE HOSES OF THE TWO SCREWDRIVERS. SECOND OBSERVATION ON (B)(6). UPON RECEIPT IN STERILIZATION, AFTER SOAKING AND PRE-DISINFECTION WITH THE WASHER IN THE OPERATING ROOM, THE 2 "FLEXIBLE" SCREWDRIVERS WERE CLEANED, BRUSHED, BLOWN, NO PARTICLES WERE OBSERVED LEAVING THE WET MATERIAL. THE HOSES WILL BE BLOWN OUT OF THE WASHER FOR OBSERVATION. THE INTERVENTION WAS COMPLETED BY USING A SECOND INSTRUMENT SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276293 ↗
• MalfunctionJan 23, 2019Particulates

  THE HOSPITAL REPORTED, BLACK PARTICLES COMING OUT OF THE SCREWDRIVER. FIRST OBSERVATION ON DECEMBER 18, THE STERILIZATION DEPARTMENT APPLIED A MANUAL RINSE (AFTER PRE-DISINFECTION IN THE OPERATING ROOM), BRUSHED, BLEW THE TWO DEVICES. SECOND OBSERVATION ON DECEMBER 27TH, UPON RECEIPT IN STERILIZATION, AFTER SOAKING AND PRE-DISINFECTION WITH THE WASHER IN THE OPERATING ROOM, THE 2 "FLEXIBLE" SCREWDRIVERS WERE CLEANED, BRUSHED, BLOWN, NO PARTICLES WERE OBSERVED LEAVING THE WET MATERIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8272528 ↗
• MalfunctionJan 2, 2019Peeled/Delaminated

  THE SHEATHING ON THE FLEXIBLE PART CAME OFF. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 10 MIN. NOT LONGER.

  Patient problems: No Code Available

  MAUDE report 8210560 ↗
• MalfunctionDec 19, 2018Break

  SCREWDRIVER BROKE OFF DURING DRIVE IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8182757 ↗
• MalfunctionDec 14, 2018Contamination /Decontamination Problem

  THE CLINIC REPORTED THE FOLLOWING EVENT : "AT THE OPENING OF THE ANCILLARY, THE SCREWDRIVER WAS COVERED WITH WHAT APPEARS TO BE IRON FILINGS. UNUSABLE WHEN PREPARING THE INSTRUMENTATION TABLE BY THE INSTRUMENTALIST. ACTION TAKEN TO CHECK THE INTERVENTION: CHANGE OF ANCILLARY BECAUSE SECOND AVAILABLE ANCILLARY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166083 ↗
• MalfunctionOct 18, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem; Contamination of Device Ingredient or Reagent

  RESIDUAL CONTAMINATION WAS DISCOVERED ON THE FLEXIBLE PART OF BOTH SCREWDRIVERS. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SCREWDRIVER FROM THE THIRD, THEN OPENED SET. THE FLEXIBLE PART OF THIS SCREWDRIVER WAS PROVIDED WITH A RUBBERY COATING WHICH A MEDICAL DEVICE COMPANY HAD MOUNTED THERE. SURGICAL DELAY OF 20 MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982161 ↗
• MalfunctionOct 18, 2018Contamination /Decontamination Problem

  RESIDUAL CONTAMINATION WAS DISCOVERED ON THE FLEXIBLE PART OF BOTH SCREWDRIVERS. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SCREWDRIVER FROM THE THIRD, THEN OPENED SET. THE FLEXIBLE PART OF THIS SCREWDRIVER WAS PROVIDED WITH A RUBBERY COATING WHICH A MEDICAL DEVICE COMPANY HAD MOUNTED THERE. SURGICAL DELAY OF 20 MIN. NOT LONGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982157 ↗