NA 292.623Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982180735), received between Apr 10, 2018 and Jun 1, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 1.1 MM GUIDE NEEDLE BROKE WHILE THE FRAGMENT WAS BEING REDUCED. X-RAYS SHOWED THAT THE NEEDLE BROKE BECAUSE TWO NEEDLES CROSSED. ONE FRAGMENT REMAINED INSIDE THE PATIENT'S BONE (LEFT DISTAL RADIUS), AND THE REMAINING FRAGMENT WAS TAKEN BY THE DOCTOR, WHO SUBSEQUENTLY DISCARDED IT. THE SPECIALIST ATTEMPTED TO REMOVE THE FRAGMENT FROM THE BONE, BUT WAS UNABLE TO DO SO AND DECIDED TO LEAVE IT IN PLACE DUE TO THE DIFFICULTY OF EXTRACTION AND BECAUSE THERE WOULD BE NO PROBLEM LEAVING IT THERE. THERE WAS NO NEED TO ADDRESS THE INCIDENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY CHANGES TO THE SURGICAL SCHEDULE OR DISCOMFORT FOR THE SPECIALIST, WHO DID REQUEST THAT THE INCIDENT BE REPORTED. AS MENTIONED PREVIOUSLY, THE REMAINING PORTION OF THE BROKEN NAIL WAS DISCARDED, WHICH IS WHY IT WAS NOT INCLUDED IN THE SURGICAL KIT. THE PATIENT WAS AFFECTED BECAUSE A SMALL FRAGMENT OF THE BROKEN GUIDE WIRE REMAINED LODGED IN THE BONE. THE SPECIALIST DECIDED TO LEAVE THIS FRAGMENT IN PLACE, EMPHASIZING THAT IT DID NOT POSE A SIGNIFICANT RISK TO THE PATIENT. DURING AND AFTER THE SURGERY, THE PATIENT'S CONDITION WAS STABLE AND WITHOUT ANY FUR

  Patient problems: Foreign Body In Patient

  MAUDE report 25355438 ↗
• MalfunctionMay 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR PATELLA FRACTURE WITH THE GUIDE WIRE. WHEN THE NURSE OPENED THE GUIDE WIRE USING (B)(6) AND TRIED TO ATTACH IT TO THE POWER TOOL, IT WAS CONFIRMED THAT THE GUIDE WIRE HAD BEEN BENT. OTHER GUIDE WIRE WAS OPENED AND USED INSTEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988642 ↗
• MalfunctionMar 15, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, UPON OPENING THE OUTER PACKAGE AND ATTEMPTING TO OPEN THE PLASTIC BAG INSIDE, IT WAS DISCOVERED THAT THE PRODUCT INSIDE WAS BENT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE PRODUCT. NO SURGICAL DELAY. PATIENT IS STABLE. THIS REPORT IS FOR ONE GUIDEWIRE ø1.1 L150 SST FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914443 ↗
• MalfunctionMar 12, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 22-FEBRUARY-2024, THE THREE THREADED GUIDES AND ONE NON-THREADED GUIDE IN QUESTION WERE TWISTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.1MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888132 ↗
• MalfunctionMar 5, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT A FIXATION OF THE CM JOINT OF THE THUMB. DURING THE SURGERY, WHEN A GUIDEWIRE WAS UNPACKED, IT APPEARED TO BE SOMEWHAT ARCHED BENT FROM A SURGEON¿S VIEW. THE GUIDEWIRE WAS USED AND ROTATED WITH K WIRE-CHUCK, BUT IT APPEARED TO BE INEFFECTIVE. THEREFORE, OTHER LESS BENT ONE WAS USED INSTEAD FOR THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) GUIDEWIRE ø1.1 L150 SST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838568 ↗
• MalfunctionOct 23, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR 5TH METATARSAL BASE FRACTURE. AFTER INSERTING THE GUIDE WIRE ONCE, THE SURGEON PULLED IT OUT HALFWAY TO CHANGE ITS DIRECTION, BUT THIS PROCESS PLACED STRESS ON THE SLEEVE AND GUIDE WIRE, CAUSING THE GUIDE WIRE TO BREAK AT THE TIP OF THE SLEEVE. THE INSERTION SITE WAS WIDENED USING A 2.7 MM HOLLOW DRILL, AND THE BROKEN PART WAS REMOVED USING TAPERED MOSQUITO FORCEPS. THE SURGEON INSERTED A HEADLESS COMPRESSION SCREW (HCS3.0) USING A NEW GUIDEWIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES DELAY. NO FRAGMENTS WERE LEFT IN THE PATIENT. PATIENT WAS STABLE. THIS REPORT IS FOR A 1.1MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989944 ↗
• MalfunctionSep 1, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR RADIAL HEAD FRACTURE WITH GUIDE WIRE. WHEN THE PRODUCT IN QUESTION WAS OPENED, IT WAS FOUND TO BE BENT. THE PRODUCT IN QUESTION WAS NOT USED IN SURGERY AND THE SURGERY WAS COMPLETED USING ANOTHER GUIDEWIRE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 1.1MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670254 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 IN WHICH THE PRODUCTS IN QUESTION WERE IMPLANTED. THE PATIENT HAS BEEN PRESENTING WITH A REACTION AT THE SITE OF THE PROCEDURE FOR OVER 1 YEAR. PRODUCTS HAVE NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 1.1MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17424254 ↗
• InjuryFeb 12, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE DUE TO LEFT SCAPHOID FRACTURE THAT OCCURRED ONE YEAR AGO WHEN A NON-UNION OF SCAPHOID MID-WAIST AND CYSTIC FORMATION NOTED IN THE PROXIMAL POLE. DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE LEFT SCAPHOID AND THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT WITHOUT INJURING THE AREA. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 1.1MM NON-THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9699922 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS FURTHER REPORTED THAT THERE WAS A FRAGMENT CAUSED BY BREAKAGE OF THE WIRE AND DID ADD TO THE OPERATION TIME. ALL PIECES WERE RETRIEVED AND REMOVED AND CONFIRMED UPON X-RAY EXAM. IT WAS UNKNOWN IF THERE WAS ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123702 ↗
• MalfunctionApr 11, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, WHILE DRILLING FOR INSERTION OF A 3.5MM CANNULATED SCREW WITH THE 2.7MM DRILL BIT ON THE 1.1MM NON-THREADED GUIDE WIRE, THE GUIDE WIRE SPLIT. A FRAGMENT OF THE BROKEN WIRE REMAINS IN THE PATIENT. THIS REPORT IS FOR ONE (1) 1.1MM NON-THREADED GUIDE WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423372 ↗
• InjuryApr 11, 2018Break; Break

  DEVICE REPORT FROM (B)(4) EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, SURGEON ATTEMPTED TO PLACE THE 1.1MM NON-THREADED GUIDE WIRE AND THE TIP OF THE NEEDLE BROKE. THE NEEDLE TIP REMAINS EMBEDDED IN PATIENT¿S BONE WITH NO POSSIBILITY OF REMOVAL, AS DOING SO COULD CAUSE DAMAGE TO THE PATIENT. THIS REPORT IS FOR ONE (1) 1.1MM NON-THREADED GUIDE WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7422181 ↗
• InjuryApr 10, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN ARTHRODESIS OF LAPIDUS PROCEDURE ON (B)(6) 2018, THE 2.0MM CANNULATED DRILL BIT BROKE INSIDE THE PATIENT WHILE SURGEON WAS DRILLING. IT WAS FURTHER REPORTED THE 1.1MM NON-THREADED GUIDE WIRE ALSO BROKE DURING THE PROCEDURE. THE BROKEN FRAGMENTS FROM BOTH DEVICES REMAIN IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. CONCOMITANT DEVICES REPORTED: DRILL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.1MM NON-THREADED GUIDE WIRE. THIS IS REPORT 2 OF 2 FOR (B)(4). .

  Patient problems: Foreign Body In Patient

  MAUDE report 7419282 ↗