NA 292.622Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982180728), received between Jan 9, 2018 and Sep 30, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Entrapment of Device

  It was reported that during the surgical procedure, the specialist proceeded with the placement of the 1.1 mm threaded tip guides for the subsequent fixation of the cannulated screw; however, during the maneuver, the distal end of one of the guides fractured, becoming lodged in the patient. In view of this event, the surgeon made the corresponding attempts to remove the fragment, but determined that the extraction was not feasible, opting to leave the tip in place to avoid further complications. It should be noted that the situation was handled by the specialist without generating setbacks, there was no discomfort on his part and the intervention continued without registering delays in the scheduled surgical time.

  Patient problems: Foreign Body In Patient

  MAUDE report 50945587 ↗
• MalfunctionSep 21, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50848777 ↗
• MalfunctionAug 25, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT A GUIDE WIRE BROKE INSIDE THE PATIENT. THE GUIDE WIRE WAS USED TO PLACE A 3.0 CANNULATED SCREW. WHEN THE SURGEON WAS REMOVING THE WIRE IT BROKE. THE WIRE WAS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22889945 ↗
• 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 THREADED GUIDE WIRE 150MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888131 ↗
• 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 THREADED GUIDE WIRE 150MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888129 ↗
• 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 THREADED GUIDE WIRE 150MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888128 ↗
• MalfunctionJul 20, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DAMAGED PRODUCT WAS RECEIVED FROM THE HOSPITAL. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT INVOLVES ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196055 ↗
• MalfunctionJun 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, DAMAGED PRODUCT WAS RECEIVED FROM THE HOSPITAL. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031727 ↗
• MalfunctionJun 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, DAMAGED PRODUCT WAS RECEIVED FROM THE HOSPITAL. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031691 ↗
• MalfunctionJun 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, DAMAGED PRODUCT WAS RECEIVED FROM THE HOSPITAL. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031658 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THREE OUT OF FOUR THREADED GUIDE WIRE WERE BENT AND WERE STICKING OUT OF THE FED EX PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845070 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THREE OUT OF FOUR THREADED GUIDE WIRE WERE BENT AND WERE STICKING OUT OF THE FED EX PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845061 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THREE OUT OF FOUR THREADED GUIDE WIRE WERE BENT AND WERE STICKING OUT OF THE FED EX PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845016 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR THREADED GUIDE WIRE WERE ALL BENT. THERE WAS NO PATIENT CONTACT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620061 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR THREADED GUIDE WIRE WERE ALL BENT. THERE WAS NO PATIENT CONTACT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620057 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR THREADED GUIDE WIRE WERE ALL BENT. THERE WAS NO PATIENT CONTACT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620055 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOUR THREADED GUIDE WIRE WERE ALL BENT. THERE WAS NO PATIENT CONTACT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM THREADED GUIDE WIRE 150MM. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620041 ↗
• InjuryOct 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019 A GUIDE WIRE BROKE DURING THE PROCEDURE, LEAVING A FRAGMENT IN THE PATIENT'S BONE. NO INFORMATION IS KNOWN ON SURGICAL DELAY OR PATIENT STATUS THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9209916 ↗
• InjuryMar 8, 2019Break; Entrapment of Device; Break; Entrapment of Device

  FURTHER IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS HAD A SATISFACTORY RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8405110 ↗
• InjuryJul 16, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A 1.1MM THREADED GUIDE WIRE 150MM BROKE OFF IN THE JOINT BALL WHILE FIXING A CAPITULUM FRACTURE OF THE DISTAL HUMERUS. THE BROKEN PIECE OF GUIDE WIRE WAS SUCTIONED OUT. NO FRAGMENTS WERE LEFT IN THE PATIENT. THREE ADDITIONAL X-RAYS WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR A 1.1MM THREADED GUIDE WIRE 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7690868 ↗
• MalfunctionMay 8, 2018Break; Break

  THIS REPORT IS AGAINST MAUDE MEDWATCH NUMBER MW5076352. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496950 ↗
• MalfunctionJan 16, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT A NAVICULAR FRACTURE PROCEDURE. DURING THE PROCEDURE, A DRILL BIT AND A GUIDE WIRE BROKE INSIDE THE PATIENT. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE FRAGMENTS; THE FRAGMENTS REMAIN IN THE PATIENT. ONE 3.0 HEADLESS COMPRESSION SCREW WAS IMPLANTED. THE SURGERY WAS COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) 1.1 MM THREADED GUIDE WIRE 150 MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7195300 ↗
• MalfunctionJan 9, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2017, THE THREADED TIP OF A GUIDE PIN BROKE OFF IN A PATIENT. IT WAS FURTHER EXPLAINED THAT WHILE THE SURGEON WAS PLACING THE GUIDE PIN FOR A 2.4 HEADLESS COMPRESSION SCREW, THE TIP OF THE THREADED TIP BROKE OFF. THE BROKEN FRAGMENT WAS RETRIEVED USING AN UNKNOWN INSTRUMENT; THE FRAGMENT WAS GRABBED AND EASILY REMOVED. THERE WAS A TEN-MINUTE DELAY DUE TO THE RETRIEVAL OF THE FRAGMENT. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. THE COMPLAINED DEVICE WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A GUIDE PIN. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176016 ↗