NA 292.72Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982180889), received between Nov 29, 2018 and Jul 19, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A REPAIR OF A TIBIAL PLATEAU, A PATIENT WAS BEING TREATED WITH THREE (3) 4.5MM CANNULATED SCREWS. APPROXIMATELY 1 CM OF THE THREADS OF ONE THE SCREWS PEELED OFF. ALSO, TWO (2) OF THE GUIDE WIRES PULLED OUT AFTER DRILLING OVER THEM. THE GUIDE WIRES WERE INSERTED USING A STRYKER DRILL AND COLLET AND IT APPEARS THAT THE COLLET IS SCORING THE GUIDE WIRES. THE SCORING IS SUFFICIENT TO CAUSE THE GUIDE WIRE TO COME OUT AFTER DRILLING AND REMOVING THE CANNULATED DRILL BIT. THE GUIDE WIRES AND DRILL BITS WERE ALL NEW FOR THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER DRILL AND COLLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . UNKNOWN DRILL BIT (PART # 310.65, LOT # PE03478, QUANTITY UNKNOWN) . UNKNOWN 4.5MM CANNULATED SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808939 ↗
• MalfunctionJul 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A REPAIR OF A TIBIAL PLATEAU, A PATIENT WAS BEING TREATED WITH THREE (3) 4.5MM CANNULATED SCREWS. APPROXIMATELY 1 CM OF THE THREADS OF ONE THE SCREWS PEELED OFF. ALSO, TWO (2) OF THE GUIDE WIRES PULLED OUT AFTER DRILLING OVER THEM. THE GUIDE WIRES WERE INSERTED USING A STRYKER DRILL AND COLLET AND IT APPEARS THAT THE COLLET IS SCORING THE GUIDE WIRES. THE SCORING IS SUFFICIENT TO CAUSE THE GUIDE WIRE TO COME OUT AFTER DRILLING AND REMOVING THE CANNULATED DRILL BIT. THE GUIDE WIRES AND DRILL BITS WERE ALL NEW FOR THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER DRILL AND COLLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . UNKNOWN DRILL BIT (PART # 310.65, LOT # PE03478, QUANTITY UNKNOWN) . UNKNOWN 4.5MM CANNULATED SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808937 ↗
• MalfunctionJul 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A REPAIR OF A TIBIAL PLATEAU, A PATIENT WAS BEING TREATED WITH THREE (3) 4.5 MM CANNULATED SCREWS. APPROXIMATELY 1 CM OF THE THREADS OF ONE THE SCREWS PEELED OFF. ALSO, TWO (2) OF THE GUIDE WIRES PULLED OUT AFTER DRILLING OVER THEM. THE GUIDE WIRES WERE INSERTED USING A STRYKER DRILL AND COLLET AND IT APPEARS THAT THE COLLET IS SCORING THE GUIDE WIRES. THE SCORING IS SUFFICIENT TO CAUSE THE GUIDE WIRE TO COME OUT AFTER DRILLING AND REMOVING THE CANNULATED DRILL BIT. THE GUIDE WIRES AND DRILL BITS WERE ALL NEW FOR THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER DRILL AND COLLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN DRILL BIT (PART # 310.65, LOT # PE03478, QUANTITY UNKNOWN). UNKNOWN 4.5 MM CANNULATED SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808936 ↗
• MalfunctionJul 19, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A REPAIR OF A TIBIAL PLATEAU, A PATIENT WAS BEING TREATED WITH THREE (3) 4.5MM CANNULATED SCREWS. APPROXIMATELY 1 CM OF THE THREADS OF ONE THE SCREWS PEELED OFF. ALSO, TWO (2) OF THE GUIDE WIRES PULLED OUT AFTER DRILLING OVER THEM. THE GUIDE WIRES WERE INSERTED USING A STRYKER DRILL AND COLLET AND IT APPEARS THAT THE COLLET IS SCORING THE GUIDE WIRES. THE SCORING IS SUFFICIENT TO CAUSE THE GUIDE WIRE TO COME OUT AFTER DRILLING AND REMOVING THE CANNULATED DRILL BIT. THE GUIDE WIRES AND DRILL BITS WERE ALL NEW FOR THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER DRILL AND COLLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . UNKNOWN DRILL BIT (PART # 310.65, LOT # PE03478, QUANTITY UNKNOWN) . UNKNOWN 4.5MM CANNULATED SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808934 ↗
• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED ON (B)(6) 2018, DURING A LEFT ELBOW PROCEDURE THE THREADED GUIDE WIRE BROKE OFF AND THE PARTIALLY THREADED SCREW SHEARED OFF. THE HEAD OF THE UNKNOWN FULLY THREADED SCREW BROKE OFF. PIECES WAS LEFT IN THE PATIENT. THERE WAS A THIRTY TO FORTY MINUTES DELAYED IN THE PROCEDURE AND WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. THERE WAS NO PLAN FOR ANOTHER SURGERY TO GET THE PIECES OUT OF THE PATIENT . THIS REPORT IS ONE (1) GUIDE WIRE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8117466 ↗