GAMMA 1320-3042Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04546540377883), received between Sep 13, 2019 and Dec 23, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Fracture; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "WHILE SURGEON WAS DRILLING A HOLE WITH A 4.2MM DRILL BIT FOR A DISTAL SCREW IN A SHORT GAMMA NAIL PROCEDURE THE TIP OF THE DRILL BIT BROKE OFF INSIDE THE PATIENT'S FEMUR. UNABLE TO REMOVE BROKEN TIP OF DRILL BIT. NEW DRILL BIT WAS ACQUIRED AND USED TO COMPLETE THE PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 23875436 ↗
• MalfunctionMay 1, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 3 DIFFERENT DRILLS BROKE DURING SURGERY. EVENT WAS SOLVED BY USING ANOTHER PRODUCT AVAILABLE (SAME REFERENCE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943840 ↗
• MalfunctionDec 20, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "DRILL BIT BREAKAGE DURING A GAMMA PER TROCHANTERIC NAILING PROCEDURE. STATIC ASSEMBLY LOCK SOUGHT BUT BIT BROKE AGAINST NAIL. PROCEDURE WAS COMPLETED BY DYNAMIC DISTAL AIMING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989729 ↗
• MalfunctionAug 15, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DAMAGED DRILL BIT INSIDE THE ANKLE JOINT BETWEEN THE SHAFT AND THE BONE AT THE TIME OF DRILLING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997144 ↗
• MalfunctionOct 27, 2023Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED: "DURING THE INSERTION OF A GAMMA NAIL IN THIS PATIENT, THE END OF THE DRILL BIT BROKE IN THE DISTAL SCREW POSITIONING SPACE, PREVENTING THE INSERTION OF A SCREW. THE BROKEN DRILL BIT WAS RETAINED. THE BROKEN PART OF THE DRILL COULD NOT BE REMOVED FROM THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 18022437 ↗
• MalfunctionSep 19, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DEVICE DAMAGED IN THE SURGICAL ACT. ACCORDING TO INFORMATION ON THE NOTIFICATION FORM, ALL FRAGMENTS WERE RECOVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777822 ↗
• MalfunctionMar 27, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE TARGETER DEVICE AS WELL AS A BROKEN DRILL BIT. UPDATE ON 03.16.2023 : "THE DISTAL TARGETER MISSED THE NAIL HOLE ON A SHORT NAIL".

  Patient problems: Insufficient Information

  MAUDE report 16618891 ↗
• MalfunctionDec 2, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING THE PROCEDURE, A PIECE OF DRILL BIT GOT STUCK IN THE PATIENT'S FEMORAL SHAFT, WHOSE BONE QUALITY WAS POOR. THE SURGEON PREFERRED NOT TO INSIST ON THIS PROCEDURE BECAUSE OF THE RISK OF DAMAGING THE BONE, GIVEN THE PATIENT'S LIFE EXPECTANCY. BECAUSE THE PIECE OF DRILL BIT REMAINED IN THE PATIENT, THE EVENT IS CONSIDERED A SERIOUS EVENT." THE PATIENT HAD METASTASES AND A VERY HARD BONE. IN NO CASE IT IS A PROBLEM OF THE DRILL. THE FACT THAT A PIECE OF DRILL REMAINS IN THE PATIENT, IS NOT SERIOUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15911569 ↗
• MalfunctionNov 29, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING DISTAL DRILLING ON THE GAMMA NAIL, THE DRILL BIT BROKE OFF IN THE NAIL. THE NAIL WAS THEN REMOVED AND CHANGED AS WELL AS THE DRILL BIT, AND THE DEBRIS OF THE DRILL BIT WAS ALSO RECOVERED. THE PROCEDURE WAS NOT DELAYED BUT WAS EXTENDED BY ABOUT 40 MINUTES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883551 ↗
• MalfunctionAug 30, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "PERTROCHANTERIC FEMUR FRACTURE. REDUCTION AND FIXATION WITH AN INTRAMEDULLARY NAIL WAS PERFORMED. DURING THE DRILLING FOR THE INSERTION OF THE DISTAL LOCKING SCREW, THE DRILL BIT BROKE WHEN IT HIT THE MEDULLARY NAIL. RETENTION OF THE DRILL BIT INSIDE THE MEDULLARY CANAL OF THE FEMUR WHICH COULD LEAD TO DIFFICULTIES IN CASE OF REMOVAL OF THE MEDULLARY NAIL."

  Patient problems: Foreign Body In Patient

  MAUDE report 15318646 ↗
• MalfunctionJul 12, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2022 DURING A GAMMA NAIL IMPLANT OPERATION, THE SURGEON, WHILE HE PROCEEDED TO DRILL THE BONE THROUGH THE STATIC HOLE - INSTRUMENTS: AIMING ARM OF THE STRYKER GAMMA3 KIT PRODUCT CODE 1320-0100 AND DRILLS PRODUCT CODE 1320-3042, WAS FOUND TO IMPACT AGAINST THE INTRAMEDULLARY NAIL EXPECTING INSTEAD TO HAVE OBTAINED FULL CENTERING ON THE THROUGH HOLE OF THE NAIL, CONSEQUENTLY BREAKING THE TIP OF THE DRILL. HE THEN PROCEEDED TO REMOVE EVERY METAL FRAGMENT AND CONTINUED MILLING WITH A SECOND CUTTER, THIS TIME PASSING THROUGH THE DYNAMIC HOLE, BUT THE EVENT WAS REPEATED THE SAME AS ABOVE, LEADING TO THE BREAKAGE OF THE SECOND CUTTER AS WELL; IN THIS INSTANCE, HOWEVER, IT WAS NOT POSSIBLE FOR HIM TO RECOVER ALL THE METAL FRAGMENTS (ONE OR MORE REMAINED STUCK IN THE CORTEX), AND CONSEQUENTLY THE PATIENT WILL UNDERGO FURTHER SURGERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 14985166 ↗
• MalfunctionJul 12, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2022 DURING A GAMMA NAIL IMPLANT OPERATION, THE SURGEON, WHILE HE PROCEEDED TO DRILL THE BONE THROUGH THE STATIC HOLE - INSTRUMENTS: AIMING ARM OF THE STRYKER GAMMA3 KIT PRODUCT CODE 1320-0100 AND DRILLS PRODUCT CODE 1320-3042, WAS FOUND TO IMPACT AGAINST THE INTRAMEDULLARY NAIL EXPECTING INSTEAD TO HAVE OBTAINED FULL CENTERING ON THE THROUGH HOLE OF THE NAIL, CONSEQUENTLY BREAKING THE TIP OF THE DRILL. HE THEN PROCEEDED TO REMOVE EVERY METAL FRAGMENT AND CONTINUED MILLING WITH A SECOND CUTTER, THIS TIME PASSING THROUGH THE DYNAMIC HOLE, BUT THE EVENT WAS REPEATED THE SAME AS ABOVE, LEADING TO THE BREAKAGE OF THE SECOND CUTTER AS WELL; IN THIS INSTANCE, HOWEVER, IT WAS NOT POSSIBLE FOR HIM TO RECOVER ALL THE METAL FRAGMENTS (ONE OR MORE REMAINED STUCK IN THE CORTEX), AND CONSEQUENTLY THE PATIENT WILL UNDERGO FURTHER SURGERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 14985161 ↗
• MalfunctionJun 17, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: A DRILL BIT RUPTURE REFERENCE 1320-3042 LOT KU78550 OCCURRED DURING A GAMMA NAIL PLACEMENT. PLACEMENT OF A 100MM CERVICAL-HEAD SCREW. PLACEMENT OF A LOCKING SCREW. PREPARATION OF THE ANCILLARY EQUIPMENT FOR DISTAL AIMING IN STATIC MOUNTING. AT THIS STAGE OF THE PROCEDURE, THE DRILL BIT IS BROKEN ON THE BONE. DRILLING WITH THE APPROPRIATE DRILL BIT. INTRAOSSEOUS DRILL BIT WITH NO FURTHER REPERCUSSIONS IS LEFT IN PLACE. POSITIONING OF THE ANCILLARY FOR DISTAL AIMING IN THE DYNAMIC MONTAGE. DRILLING OF THE DRILL BIT. PLACEMENT OF A 35 MM CORTICAL SCREW. A FINAL SATISFACTORY FACE-PROFILE RADIOGRAPHIC CHECK. ABUNDANT WASHING. PLANE BY PLANE CLOSURE WITH SKIN STAPLES. BANDAGE. POST-OPERATIVE INSTRUCTIONS: POST-OPERATIVE X-RAY TO BE PERFORMED. RECENT THAN ICING. WOUND CARE TO BE PERFORMED EVERY 2 DAYS WITH STAPLES REMOVED ON THE 15TH POSTOPERATIVE DAY. SITTING AND SUPPORT ALLOWED. CONSULTATION APPOINTMENT IN 6 WEEKS. NB: INCIDENT DURING SURGERY: DRILL BIT BROKEN AT THE FEMORAL SHAFT AND LEFT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14739168 ↗
• MalfunctionMar 23, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "A NAIL FOR THE RIGHT SIDE WAS MISTAKENLY INSERTED FOR A FRACTURE OF THE LEFT FEMUR. CONTACT BETWEEN THE DRILL AND THE NAIL DURING DISTAL DRILLING, RESULTING IN BREAKAGE OF THE DRILL TIP AND REMAINING IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 13860283 ↗
• MalfunctionAug 2, 2021Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT : "DURING THE PROCEDURE, WHILE DRILLING THE GAMMA NAIL LOCK, THE DRILL BIT BROKE OFF AND REMAINED IN PLACE IN THE FEMUR. THE ATTEMPT TO REMOVE IT WAS UNSUCCESSFUL. AS A RESULT, THE DEVICE HAD TO BE CHANGED AND THE OPERATION TIME WAS LONGER THAN EXPECTED." IT WAS FURTHER REPORTED THAT THE SURGICAL DELAY WAS SLIGHT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12264220 ↗
• MalfunctionJan 13, 2021Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  AS REPORTED: "IN THE PROCEDURE OF THE GAMMA NAIL, THE BIT OF 4.2 IS PASSED TO BLOCK DISTAL AND AT THE MOMENT OF PASSING IT THE POINT IS BENDING, WHEN TRYING TO PASS IT AGAIN, THE POINT OF THE BIT IS SPLITTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168084 ↗
• MalfunctionJul 27, 2020Fracture; Fracture

  THE CUSTOMER REPORTED TO THE SALES REP THAT : "WHEN DRILLING THE FEMUR FOR LOCKING ON A GAMMA NAIL PLACEMENT, THE DRILL BIT BROKE OFF AND GOT STUCK IN THE PATIENT'S FEMUR. THE DRILL BIT REMAINED IN THE FEMUR. PRACTITIONER PREFERRED TO LEAVE THE HARDWARE IN PLACE, MONITOR THE PATIENT." ADDITIONAL INFORMATION RECEIVED: "THE PROCEDURE COULD NOT BE COMPLETED CORRECTLY (INCOMPLETE SCREWING OF THE DISTAL LOCKING DEVICE). THE PROCEDURE WAS DELAYED BY 20 MINUTES. THERE WAS NO NEED FOR FURTHER INTERVENTION. THE BROKEN PART LEFT IN THE PATIENT MEASURES 1.5 CM. THE BONE WASN'T PARTICULARLY HARD."

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10329696 ↗
• MalfunctionNov 16, 2019Fracture; Fracture

  THE CUSTOMER REPORTED TO OUR SALES REP THAT : "I HAVE A GAMMA NAIL HANDPIECE TO SEND BACK FOR QUALITY CONTROL BECAUSE WE HAD A PROBLEM THIS WEEKEND. [SURGEON], DURING HIS INTERVENTION, NOTICED THAT THE VIEWFINDER WAS A LITTLE "SCREWED UP" AND AS A RESULT THE DRILL BROKE IN THE PATIENT."

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9333092 ↗
• MalfunctionSep 13, 2019Break; Fracture; Material Perforation; Fracture

  AS REPORTED: "DURING THE SURGERY OF MEDUALR INTERLOCKING, WHEN THE DOCTOR IS [MAKING] THE PERFORATION FOR THE DISTAL BLOCK THE DRILL OF 4.2 BROKE [INSIDE] THE PATIENT. THE SMALLEST PART OF THE DRILL WAS LEAVE INSIDE THE PATIENT BECAUSE WAS NOT POSSIBLE TO EXTRACT IT." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9050622 ↗