NA 292.16Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20886982180374), received between Jan 10, 2018 and Apr 28, 2026 — classified as 5 injuries, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 THAT 1.6MM K-WIRE WOULD NOT BACK OUT OF PROXIMAL K-WIRE GUIDE HOLE, AS IT SEEMED TO BE COLD-WELDED. GUIDE WAS TAKEN OFF THE PLATE AFTER PROXIMAL HOLES WERE FILLED AND THE 1.6 K-WIRE CAME WITH. THE PROCEDURE WAS ORIF PROXIMAL HUMERUS. NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015427 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REQUESTING INFORMATION REGARDING ANY POTENTIAL RECALLS AND MATERIAL MAKEUP OF HER PLATE AND SCREWS DUE TO SYMPTOMS SHE IS EXPERIENCING SINCE THE IMPLANTATION IN (B)(6) 2016 FOR A BROKEN ANKLE AND TIBIA. SYMPTOMS BEGAN 9 MONTHS AFTERWARD AND INCLUDE HYPERSENSITIVITY, AN IMMUNE RESPONSE THAT HAS "MESSED UP HER SYSTEM," HIGH TITER, DISCOID LUPUS, SKIN ISSUES, BODY ACHES, FATIGUE, FEVERS, JOINT PAIN, STIFFNESS, REDNESS, AND EXTREME FATIGUE. PATIENT'S SURGEON WOULD LIKE TO PERFORM AN MRI AND POTENTIALLY REMOVE THE DEVICE.

  Patient problems: Fatigue; Fever; Hypersensitivity/Allergic reaction; Muscular Rigidity; Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22986052 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2022 TO IMPLANT THE DEVICE. ON (B)(6) 2023, IT APPEARED THAT THE PATIENT HAD DEVELOPED A REACTION ISSUE WITH THE TITANIUM IN HIS LOWER LEG. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 10 OF 11 FOR (B)(4). THIS REPORT INVOLVES ONE (1) 1.6 KIRSCHNER WIRE W/TRCR POINT 150-10PK.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16825154 ↗
• MalfunctionFeb 13, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 19-JANUARY-2023, THE K-WIRE IN QUESTION WAS DELIVERED BENT. THE PRODUCT CANNOT BE USED. THERE WAS NO PATIENT INVOLVEMENT, THE ISSUE WAS DISCOVERED UPON DELIVERY OF THE ITEM. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362202 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE OR/MDRD MANAGER INFORMED THE SALES CONSULTANT OF A CONCERN OVER THE PACKAGING OF 10 PACK K-WIRES. THERE HAVE BEEN THREE INCIDENTS IN THE PAST 6 MONTHS WHERE A TROCAR POINT WIRE HAS COME RIGHT THROUGH THE PACKAGING AND INJURED AN MDRD STAFF'S HAND. THE INCIDENTS OCCURRED AFTER THE RESTOCKING OF THE INSTRUMENT TRAY DURING THE REPROCESSING/STERILIZING PROTOCOLS. THE MOST RECENT INCIDENT WAS MORE SEVERE IN THAT THE WIRE WENT THROUGH THE HAND (PREVIOUS INCIDENTS WERE ONLY MINOR PRICKS/CUTS). THESE INCIDENTS HAVE ALL HAPPENED WHEN ONLY 1 OR 2 WIRES ARE LEFT IN THE PACK AND UPON CLOSING THE PACK, THE WIRE HAS EASILY GONE THROUGH THE PLASTIC. THE SALES CONSULTANT PROVIDED SUGGESTIONS TO AVOID THESE INCIDENTS BUT THERE IS A CONCERN OVER THE PACKAGING AND THE STAFF BELIEVES THE PLASTIC FEELS MORE "FLIMSY" THAN IN THE PAST. THIS REPORT IS FOR A 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4) AND CAPTURES THE SECOND INCIDENT. THE FIRST AND THIRD INCIDENTS ARE CAPTURED UNDER (B)(4), RESPECTIVELY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11828952 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT IT WAS NOTIFIED BY THE CUSTOMER FOR CONCERN OVER THE PACKAGING OF 10 PACK K-WIRES. THERE HAVE BEEN 3 INCIDENTS IN THE PAST 6 MONTHS WHERE A TROCAR POINT WIRE HAS COME RIGHT THROUGH THE PACKAGING AND INJURED AN MDRD STAFF'S HAND. ALSO NOTIFIED THAT THE MOST RECENT INCIDENT WAS MORE SEVERE WHEN THE WIRE WENT THROUGH THE HAND. IT OCCURRED IN MDRD AFTER THE RESTOCKING OF THE INSTRUMENT TRAY DURING THEIR REPROCESSING/STERILIZATION PROTOCOLS. THERE WAS NO PATIENT INVOLVEMENT ARE REPORTED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: Needle Stick/Puncture

  MAUDE report 11827907 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CAPTURES THE FIRST INCIDENT. THE SECOND AND THIRD INCIDENTS ARE CAPTURED UNDER (B)(4) AND (B)(4), RESPECTIVELY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11825774 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING A FIXATION OF A DISTAL HUMERUS FRACTURE, A KIRSHNER WIRE WITH TROCHAR POINT BROKE INSIDE THE PATIENT. THE WIRE BROKE INTO TWO SEPARATE PIECES AND WAS LEFT INSIDE THE DISTAL HUMERUS. THE WIRE WAS NOT PROTRUDING FROM THE BONE AND COULD NOT BE EXTRACTED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8446012 ↗
• MalfunctionMar 19, 2018Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, A 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM WAS BROKEN. THE BROKEN PART WAS LEFT INTO THE PATIENT¿S BONE (THE HUMERUS HEAD). THERE IS NO ADDITIONAL INFORMATION. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7348954 ↗
• MalfunctionMar 2, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A PROCEDURE AN OPEN REDUCTION INTERNAL FIXATION OF A FRACTURE IN BOTH FOREARMS. DURING THE PROCEDURE, A 1.6MM K WIRE BROKE. IT WAS FURTHER EXPLAINED THAT THE SURGEON PLACED A 3.5 LOCKING COMPRESSION PLATE USING AN UNKNOWN LOCKING GUIDE AND WIRE GUIDE. HE THEN ATTACHED THE 1.6MM K WIRE AS A TEMPORARY FIXATION AND AS HE PULLED THE GUIDE WIRE TO REMOVE IT FROM THE PLATE THE WIRE MORE THAN LIKELY BECAME FATIGUED AND BROKE DURING REMOVAL. THE SURGEON OVER DRILLED USING A CANNULATED DRILL BIT AND HE COULD EASILY REMOVE THE BROKEN PIECE OF THE GUIDE WIRE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, NO UNANTICIPATED X-RAYS WERE REQUIRED AND THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAYS. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: 3.5 LOCKING COMPRESSION PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7309606 ↗
• MalfunctionJan 10, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE LEFT DISTAL HUMERUS, PART OF THE 1.6 MM K-WIRE USED TO HOLD THE PLATE BROKE WHEN THE SURGEON WAS TRYING TO REMOVE IT AFTER THE FIXATION OF THE SCREWS IN THE PLATE. THE FRAGMENTS GENERATED WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICE REPORTED: 2.7 MM/3.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE 4 HOLE LEFT 111 MM LONG (PART 02.117.704, LOT NUMBER UNKNOWN, QUANTITY 1), 2.7 MM/3.5 MM VA-LCP LATERAL DISTAL HUMERUS PLATE 1 HOLE LEFT 69 MM SHORT (PART 02.117.901, LOT NUMBER UNKNOWN, QUANTITY 1), 2.7 MM/3.5 MM VA-LCP PROXIMAL OLECRANON PLATE 2 HOLE LEFT 73 MM (PART 02.107.102, LOT NUMBER UNKNOWN, QUANTITY 1), AND SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178126 ↗