NA 323.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982190741), received between Mar 17, 2017 and Oct 4, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A DRILL SLEEVE WAS BREAKING DRILLS. THIS REPORT IS FOR A 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369122 ↗
• MalfunctionJul 1, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS UNABLE TO BE STERILIZED OR ASSEMBLED DUE TO CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19644749 ↗
• MalfunctionJul 1, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS UNABLE TO BE STERILIZED OR ASSEMBLED DUE TO CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19644742 ↗
• MalfunctionJul 1, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS UNABLE TO BE STERILIZED OR ASSEMBLED DUE TO CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19644737 ↗
• MalfunctionJan 11, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING SURGERY, THE SURGEON COMPLAINED THAT THE DRILL SLEEVE WAS NOT THREADING PROPERLY. IT IS WORN AND WILL NOT THREAD INTO PLATES. IT WAS DISCARDED DURING THE PROCEDURE AND A DIFFERENT SLEEVE WAS USED. THE DISCARDED DRILL SLEEVE WITH DAMAGED THREADS REQUIRES REPLACEMENT. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 2.7 HEAD LCP2.4 W/SCAL- THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18494942 ↗
• MalfunctionAug 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE STRIPPED TWO UNKNOWN DRILL BITS. THE DRILL BIT WOULD NOT GO THROUGH THE GUIDE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS MO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: UNK - DRILL BITS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 2). THIS REPORT IS FOR ONE (1) 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448424 ↗
• MalfunctionDec 3, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR DISTAL FIBULA FRACTURE. WHEN THE SURGEON BENT A PLATE AFTER CONNECTING THE DRILL GUIDE TO THE PLATE, THE SCREW PART OF THE DRILL GUIDE BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN PLATE BENDER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403540 ↗
• MalfunctionMay 23, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVE AND DRILL BIT WERE BROKEN DURING DRILLING. PATIENT CONDITION AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A 2.0 MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8638638 ↗
• MalfunctionDec 3, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) CLAVICLE PROCEDURE, THE UNKNOWN DRILL WAS LODGED IN THE THREADED DRILL GUIDE WITH DEPTH GAUGE AND WAS UNABLE TO BE USED. THE SURGEON REMOVED THE UNKNOWN DRILL FROM THE DRILL GUIDE BY PULLING AND USING A TWISTING MOTION. AN INDENTION WAS FOUND ON THE INNER PART OF THE DRILL GUIDE AND WAS BELIEVED THAT INDENTION WAS THE CAUSE OF THE INCIDENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRILL (PART #232. UNKNOWN, LOT #UNKNOWN, QUANTITY #1). THIS REPORT IS FOR ONE (1) 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127116 ↗
• MalfunctionOct 4, 2018Device-Device Incompatibility; Misassembled During Installation; Device-Device Incompatibility; Misassembled During Installation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE WAS BROKEN. THE PRODUCT THREADS WERE STRIPPED AND WOULD NOT THREAD INTO THE PLATE. IT IS UNKNOWN IF THERE WERE PATIENT AND SURGICAL INVOLVEMENT. UPON MANUFACTURER RECEIPT OF THE DEVICE, IT WAS NOTED THAT SOME OF THE MARKING PAINT WAS MISSING. CONCOMITANT DEVICES: TRAUMA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937155 ↗
• MalfunctionJul 23, 2018Mechanical Problem; Mechanical Problem

  (B)(6) REPORTS THAT ON AN UNKNOWN DATE, THE LOCKING COMPRESSION PLATE (LCP) DRILL GUIDE WOULD NOT THREAD INTO THE SCREW HOLE. IT IS UNKNOWN IF THERE WAS A SURGICAL PROCEDURE OR PATIENT INVOLVEMENT. CONCOMITANT DEVICE: LOCKING COMPRESSION PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710231 ↗
• MalfunctionMar 17, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THREE DEVICES MALFUNCTIONED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2017. THE THREADED DRILL GUIDE WOULD NOT THREAD INTO THE PLATE PROPERLY AND WAS WOBBLY. TWO SCREWDRIVER SHAFTS WOULD NOT SELF-RETAIN SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER INSTRUMENTS WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE WITH NO ISSUES. CONCOMITANT DEVICES REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); SCREWS (PART # 210.1XX, LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412925 ↗