NA 312.14Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982187604), received between Feb 8, 2017 and Aug 22, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE DRILL GUIDE HAS A BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042506 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE DOUBLE DRILL SLEEVE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR 1 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402038 ↗
• MalfunctionOct 22, 2020Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2020, A DOUBLE DRILL SLEEVE WAS BENT AND DRILL BIT WOULD NOT PASS THROUGH THE DOUBLE DRILL SLEEVE AND THE SIDE DOOR OF A LOCKING COMPRESSION PLATE (LCP) MINI FRAGMENT GRAPHIC CASE BROKE OFF. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL BIT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 1.5 MM/1.1 MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718677 ↗
• MalfunctionOct 19, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS DISCOVERED TO BE BROKEN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10696882 ↗
• InjurySep 25, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THE SURGEON WANTED TO USE A LAG SCREW USING THE COMPACT HAND SET. HE HAD ALREADY DRILLED A TWO (2) MILLIMETER HOLE NEAR THE CORTEX. HE WANTED TO USE THE DRILL SLEEVE TO CENTRALIZE THE HOLE TO DRILL THE FAR CORTEX. AFTER DRILLING, IT WAS NOTED THE TIP OF DRILL SLEEVE LOOKED BROKEN. IT WAS NOTED IT HAD GOTTEN STUCK IN THE PATIENT¿S BONE. THE PROCEDURE WAS COMPLETED USING THE OTHER END OF THE DRILL SLEEVE TO COMPLETE THE DRILLING.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10588616 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A DRILL SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) 1.5MM/1.1MM DOUBLE DRILL SLEEVE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217661 ↗
• MalfunctionJun 29, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PARTS WERE DETECTED AS DAMAGED DURING INTERNAL INSPECTION OF LOANER KITS. REPORTEDLY THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A 1.5 MM/1.1 MM DOUBLE DRILL SLEEVE THAT WAS REPORTEDLY BROKEN. THIS IS REPORT 25 OF 25 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6676740 ↗
• InjuryMay 8, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE DOUBLE DRILL SLEEVE BROKE DURING AN INITIAL CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2017. THE SURGEON WAS DRILLING A HOLE USING THE DOUBLE DRILL SLEEVE, DRILL BIT, AND COMPETITOR¿S DRILL WHEN THE DOUBLE DRILL SLEEVE BROKE. THE SURGEON TOOK ONE ADDITIONAL X-RAY AND ATTEMPTED TO RETRIEVE THE FRAGMENT USING THE SAME DRILL BIT BUT WAS UNSUCCESSFUL. THE FRAGMENT WAS LEFT IN THE PATIENT¿S BONE. THE SURGEON PROCEEDED WITH SURGERY AND RE-DRILLED USING THE SAME DRILL BIT AND DRILL. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE ADDITIONAL X-RAY, ATTEMPT TO RETRIEVE THE FRAGMENT, AND RE-DRILLING CAUSED A TWO (2) MINUTE SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THERE IS NO PLAN AT THIS TIME TO RETRIEVE THE EMBEDDED FRAGMENT. CONCOMITANT MEDICAL PRODUCTS: 1.1MM DRILL BIT, MINI QUICK COUPLING (PART #: 310.111, LOT #: UNKNOWN, QTY. 1), COMPETITOR¿S POWER DRILL (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6553315 ↗
• MalfunctionFeb 8, 2017Break; Component Missing; Break; Component Missing

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, A DOUBLE DRILL SLEEVE WAS FOUND MISSING A SIDE CONNECTOR 1.1, AFTER A SURGICAL PROCEDURE. IT WAS LOST IN THE STERILIZATION DEPARTMENT. NO PATIENT INVOLVEMENT REPORTED. DURING THE MANUFACTURER INVESTIGATION PROCESS IT WAS IDENTIFIED THAT THE DISTAL STEP OF THE 1.1 MM DRILL SLEEVE HAS BROKEN OFF. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON FEBRUARY 2, 2017. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6311729 ↗