NA 214.554Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982154231), received between Nov 29, 2018 and Jun 21, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  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 BROKE 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. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. FOREIGN BODY WAS RETAINED IN THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER DRILL AND COLLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). UNKNOWN 4.5 MM CANNULATED SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8722572 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON WAS REPAIRING A MEDIAL EPICONDYLE FRACTURE OF THE DISTAL HUMERUS. DURING THE PROCEDURE, THE THREAD OF THE FIRST CANNULATED SCREW UNRAVELED. WHILE THE SURGEON WAS INSERTING SECOND CANNULATED SCREW BY HAND OVER A GUIDE WARE, THE TIP OF THE SCREW BROKE AND REMAINED IN THE PATIENT. SURGEON RECOVERED BOTH SCREWS AND THE THREADS OF ONE OF THE SCREWS WHICH BASICALLY RAVELED, UNCOILED OUT OF THE SHAFT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: GUIDE WIRE (PART 292.72, LOT UNKNOWN, QUANTITY 1) , WASHER (PART 219.910, LOT L804246, QUANTITY 1) , SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3) . THIS REPORT IS FOR ONE (1) CANNULATED SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244751 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON WAS REPAIRING A MEDIAL EPICONDYLE FRACTURE OF THE DISTAL HUMERUS. DURING THE PROCEDURE, THE THREAD OF THE FIRST CANNULATED SCREW UNRAVELED. WHILE THE SURGEON WAS INSERTING SECOND CANNULATED SCREW BY HAND OVER A GUIDE WARE, THE TIP OF THE SCREW BROKE AND REMAINED IN THE PATIENT. SURGEON RECOVERED BOTH SCREWS AND THE THREADS OF ONE OF THE SCREWS WHICH BASICALLY RAVELED, UNCOILED OUT OF THE SHAFT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: GUIDE WIRE (PART 292.72, LOT UNKNOWN, QUANTITY 1) , WASHER (PART 219.910, LOT L804246, QUANTITY 1), SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS REPORT IS FOR ONE (1) CANNULATED SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244748 ↗
• 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) 4.5MM CANNULATED SCREW PARTIALLY THREADED/54MM THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR PC-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8117463 ↗