NA 700347Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540368973), received between Oct 21, 2016 and Mar 5, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Fracture

  IT WAS REPORTED THAT ""LEFT ANKLE FIXATION, USED THE 2.5 STRYKER DRILL BIT (700347), WHICH SNAPPED, LEAVING 2CM OF DRILL BIT WITHIN THE PATIENTS LEFT MEDIAL MALLEOLUS. THE SURGEON WAS MR FERGUSSON. THE INCIDENT OCCURRED DURING THE PRIMARY SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND THEREFORE NO ADVERSE CONSEQUENCES DUE TO DELAYS. THE CASE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DRILL BIT AND THE INCIDENT DISCUSSED WITH ORTHOPAEDIC COLLEAGUES ON THE MAINLAND IMMEDIATELY AT THE END OF THE CASE. THE FINAL OUTCOME WAS THAT THE FRACTURE WAS REDUCED AND STABILISED WITH GOOD POSITIONING OF THE METALWORK AND JOINT SPACES. THE SURGEON DOES NOT ANTICIPATE ANY LONG-LASTING EFFECTS AS THERE IS THE ADDITIONAL FIXATION METALWORK ALSO IN SITU. THE OTHER IMPLANTS USED WERE STRYKER 8-HOLE 1/3 TUBULAR PLATE, CORTICAL AND CANCELLOUS SCREWS AND X2 K-WIRES FOR STABILISATION AND THEN REMOVED. I CANNOT BE CERTAIN HOW LONG THE DRILL BIT HAS BEEN IN USE. THE TRAY WHERE THE DRILL BIT HAS BEEN IN USE AS A REUSABLE ITEM WAS INTRODUCED IN 2008 AND THAT TRAY HAS BEEN PROCESSED 117 TIMES. WE HAVE HAD, UP UNTIL RECENTLY 2 OF THE DRILL BITS ON THE TRAY SO VERY DIFFICU

  Patient problems: Foreign Body In Patient

  MAUDE report 24521792 ↗
• InjuryDec 16, 2025Fracture; Fracture

  AS REPORTED: "GOLD 2.5 DRILL BIT BROKE WITHIN PATELLA DURING USE BY SURGEON. ATTEMPT WAS MADE TO RETRIEVE BROKEN DRILL BIT. DRILL BIT COULD NOT BE RETRIEVED WITHOUT CAUSING DAMAGE TO PATELLA. DRILL BIT REMAINS EMBEDDED IN PATELLA. SURGEON WILL PROVIDE DISCLOSURE TO PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 23818565 ↗
• MalfunctionAug 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN THE PRODUCT IN QUESTION WAS USED FOR DRILLING TO PLACE EXETER MESH ON THE ACETABULAR SIDE FOR REVISION OF ANOTHER COMPANY'S THA, THE DRILL BROKE OFF DUE TO INTERFERENCE WITH ANOTHER SCREW. ABOUT 1.5 CM OF THE TIP WAS LEFT BEHIND IN THE BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 22877646 ↗
• MalfunctionJun 27, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED: "DRILL BIT TIP BROKE OFF IN PATIENTS TIBIA".

  Patient problems: Foreign Body In Patient

  MAUDE report 22346884 ↗
• MalfunctionMar 14, 2020Fracture; Fracture

  IT WAS REPORTED BY A NURSE THAT: " WHEN USING THE MOTOR WITH THE 2.5 DIAMETER DRILL BIT (STRAPPING BOX N° 3), THIS ONE BROKE OFF IN THE PATIENT'S PATELLA. CLINICAL CONSEQUENCES: THE PATIENT HAS A PIECE OF DRILL BIT IN THE PATELLA."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9832760 ↗
• MalfunctionFeb 5, 2020Fracture; Fracture

  AS REPORTED: "USE RIM MESH FOR ACETABULAR. IT BREAKS WHEN USING A DRILL TO FIX THE MESH. THE THIN AND HARD BONE AND THE LONG DRILLING MAY HAVE MADE IT MORE FRAGILE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9674148 ↗
• MalfunctionDec 17, 2019Fracture; Fracture

  IT WAS REPORTED, DURING THA SURGERY, THE DRILL BIT BROKE WHEN THE SURGEON WAS DRILLING TO THE HOLE OF THE MESH. THE TIP OF THE DRILL BIT WAS REMAINED TO THE PATIENT. THIS CASE IS REVISION DUE TO INFECTION WITH NON-STRYKER IMPLANTS. THE INFORMATION DETAILS OF THE PRIMARY SURGERY ARE UNKNOWN. BEFORE THE REVISION SURGERY, CEMENT MOLDING WITH ANTIBIOTICS WAS PERFORMED.

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

  MAUDE report 9478333 ↗
• MalfunctionMar 28, 2019Break

  THE DRILL BIT BROKE OFF DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461815 ↗
• MalfunctionJan 29, 2019Break

  PRIMARY PROCEDURE, LEFT PROXIMAL HUMERUS. IT WAS REPORTED THAT A DRILL BIT BOUND UP IN THE 2.5 DRILL GUIDE AND GOT STUCK. WHEN TRYING TO REMOVE THE BIT, APPROXIMATELY 60MM BROKE OFF IN THE GUIDE. PROCEDURE WAS COMPLETED FREE-HANDED, WITH A SURGICAL DELAY OF APPROXIMATELY 2 MINUTES REPORTED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Code Available

  MAUDE report 8287414 ↗
• MalfunctionAug 15, 2018Break; Difficult to Remove

  DURING ACETABULAR IMPACTION BONE GRAFT SURGERY, THE DRILL BIT BROKE AND WAS LEFT INSIDE THE PATIENT WHEN DRILLING 2ND SCREW HOLE. SINCE IT WAS IMPOSSIBLE TO RETRIEVE THE BROKEN DRILL BIT, THE SURGERY WAS CONTINUED WITH ANOTHER DRILL BIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7784905 ↗
• MalfunctionOct 21, 2016Fracture; Fracture

  DURING SPS SURGERY, THE DRILL BROKE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6048564 ↗