NA 03.133.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982269980), received between Nov 19, 2021 and Mar 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713690 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A FEW DRILL GUIDES WERE NO LONGER LOCKING INTO THE PLATE. THERE WAS NO PATIENT IMPACT. THIS WAS IDENTIFIED PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713577 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2.7MM LOCKING TOWERS WERE NOT FITTING INTO THE PLATE PROPERLY AND SHOULD BE REPLACED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881805 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2.7MM LOCKING TOWERS WERE NOT FITTING INTO THE PLATE PROPERLY AND SHOULD BE REPLACED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881804 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2.7MM LOCKING TOWERS WERE NOT FITTING INTO THE PLATE PROPERLY AND SHOULD BE REPLACED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881790 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2.7MM LOCKING TOWERS WERE NOT FITTING INTO THE PLATE PROPERLY AND SHOULD BE REPLACED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881789 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 2.7MM LOCKING TOWERS WERE NOT FITTING INTO THE PLATE PROPERLY AND SHOULD BE REPLACED. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881787 ↗
• MalfunctionOct 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH DHP FOR THE DISTAL HUMERUS. DOUBLE PLATING AT 90-DEGREE ANGLE WAS PERFORMED. THE SCREW IN QUESTION WAS INSERTED INTO THE MOST DISTAL SCREW HOLE OF THE INTERNAL PLATE. ALL THE SCREWS WERE INSERTED INTO THE REQUIRED SCREW HOLES. FLEXION AND EXTENSION OF THE ELBOW JOINT SHOWED LIMITED EXTENSION WHILE CHECKING THE IMAGE BEFORE CLOSURE. IT WAS FOUND THAT THE SCREW IN QUESTION THAT WAS HAVING DIFFICULTY CONNECTING THE DRILL SLEEVE BEHAVED THE SAME WAY. WHEN THE SURGEON TRIED TO REMOVE THE SCREW, IT WAS BROKEN OFF AT THE SCREW HEAD AND THE SCREW SHAFT REMAINED IN THE BONE. DRILLING WAS PERFORMED AGAIN, AND A NEW SCREW WAS INSERTED PROPERLY. THE SURGEON CONFIRMED WITH THE IMAGE THAT THERE WAS NO BROKEN SCREW, AND THE WOUND WAS CLOSED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. SINCE THIS WAS A DIFFICULT AREA TO CONNECT THE DRILL SLEEVES, THE SURGEON AND SENIOR PHYSICIAN GUESSED THAT A TECHNICAL ERROR CAUSED THE SCREW TO BE INSERTED IN THE INCORRECT POSTERIOR DIRECTION, WHICH WAS OUTSIDE THE BONE AND INTERFERED WITH THE OLECRANON DURING EXTENSION, CAUSING IT TO BREAK. THE DRILL SLEEVES USED FOR C

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20506859 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344819 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INTRAOPERATIVELY DURING A DISTAL FEMUR, LOCKING TOWER STRIPPED THE VA CONDYLAR HOLE. THE PLATE WAS NOT BILLED TO PATIENT. DURING THE SAME SURGERY DURING AN ORIF PATELLA PROCEDURE LOCKING TOWER DID NOT THREAD INTO PLATE, SO IT WAS NOT BILLED TO PATIENT EITHER. IT WAS UNSURE IF IT WAS DUE TO BENDING OF PLATE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) VA LOCK PATELLA PL 2.7 ANT CORE SM SST THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480431 ↗
• MalfunctionJan 9, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INTRAOPERATIVELY DURING A DISTAL FEMUR, LOCKING TOWER STRIPPED THE VA CONDYLAR HOLE. THE PLATE WAS NOT BILLED TO PATIENT. DURING THE SAME SURGERY DURING AN ORIF PATELLA PROCEDURE LOCKING TOWER DID NOT THREAD INTO PLATE, SO IT WAS NOT BILLED TO PATIENT EITHER. IT WAS UNSURE IF IT WAS DUE TO BENDING OF PLATE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP. THIS IS REPORT 1 OF 5 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480326 ↗
• MalfunctionMay 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DOCTOR SPLIT THE 0.8 DRILL BIT AND GUIDE FOR THE 2.7 THREADED BIT IN TWO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM THRDD GUIDE F/ 2.7MM SCR VA AND LCP. THIS IS REPORT 1 OF 2 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930228 ↗
• MalfunctionOct 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION OF THE CLAVICLE. THE SURGEON COMMENTED THAT THE NUMBER OF DRILL GUIDE WITH SCREWS WAS NOT ENOUGH. AT LEAST 3 WERE NEEDED. HE ALSO COMMENTED THAT THE DEPTH GAUGE WAS TOO LONG, THE SCREWDRIVER WAS TOO LONG AND HARD TO HANDLE, AND THE 2MM DRILL TIP WAS TOO LONG. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM THRDD GUIDE F/ 2.7MM SCR VA AND LCP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536877 ↗
• MalfunctionApr 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR HUMERAL CONDYLE FRACTURE SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT AN UNKNOWN LOCKING SCREW DEVICE DID NOT LOCK INTO THE FIXATION PLATE DEVICE AFTER DRILLING WITH A THREADED GUIDE DEVICE (03.133.008). ACCORDING TO THE REPORT, THE SURGEON REMOVED THE SCREW TO CHECK THE DIRECTION AND REINSERTED IT BUT STILL DID NOT LOCK. IT WAS REPORTED THAT THE SURGEON USED DRILL GUIDE DEVICE (03.133.007), AND EVEN THOUGH HE CHANGED DIRECTION AND DRILLED, HE COULD NOT LOCK IT TO THE PLATE. IT WAS REPORTED THAT THE EVENT OCCURRED IN BOTH THE 2ND AND 3RD HOLES FROM THE DISTAL END, SO THE SURGEON TRIED OTHER SCREW HOLES AND THEY WERE ABLE TO LOCK WITHOUT PROBLEMS. ANOTHER FIXATION PLATE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) THREADED DRILL GUIDE 2 F/SCREW 2.7 F/VA+ D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137160 ↗
• MalfunctionNov 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF DISTAL END OF HUMERUS WITH THE DRILL GUIDE IN QUESTION. IT WAS DIFFICULT TO ATTACH A PLATE, ANOTHER DRILL GUIDE WAS USED AND IT SMOOTHLY ATTACHED TO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY (30) MINUTES DELAY. THE SURGEON POINTED OUT THAT, INITIAL DRILL GUIDE MIGHT HAVE BEEN DIFFICULT TO ATTACH TO THE PLATE BECAUSE THE THREADING WAS WORN OUT. CONCOMITANT DEVICE REPORTED: UNK - PLATES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) THREADED DRILL GUIDE 2 F/SCREW 2.7 F/VA+. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847173 ↗