NA 419.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982214836), received between Aug 29, 2019 and Feb 8, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6.5 X 160MM CANNULATED SCREW WAS IMPLANTED WITH A 13MM WASHER TRANSSACRAL ACROSS S1. UPON TIGHTENING OF THE SCREW, THE 13MM WASHER BROKE. SURGERY WAS DELAYED BY 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCES/OUTCOME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328561 ↗
• InjuryJan 23, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PINNING OF THE RIGHT HIP ON (B)(6) 2021 TO TREAT INTERTROCHANTERIC FRACTURE. THE PATIENT SUFFERED SEVERE PAIN AND LACK OF MOBILITY; HER HIP WAS UNABLE TO HEAL PROPERLY, AND SHE HAS PERMANENT DAMAGE IN HER HIP WHICH HAS CAUSED EMOTIONAL DISTRESS. ON OR ABOUT AUGUST 2021, THE PATIENT UNDERWENT SURGERY TO REMOVE THE SCREWS WHICH HAD BECOME LOOSE AND HINDERED HEALING OF THE HIP. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Distress; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16225946 ↗
• InjuryJan 23, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS PINNING OF THE RIGHT HIP ON (B)(6) 2021 TO TREAT INTERTROCHANTERIC FRACTURE. THE PATIENT SUFFERED SEVERE PAIN AND LACK OF MOBILITY; HER HIP WAS UNABLE TO HEAL PROPERLY, AND SHE HAS PERMANENT DAMAGE IN HER HIP WHICH HAS CAUSED EMOTIONAL DISTRESS. ON OR ABOUT (B)(6) 2021, THE PATIENT UNDERWENT SURGERY TO REMOVE THE SCREWS WHICH HAD BECOME LOOSE AND HINDERED HEALING OF THE HIP. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Distress; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16225909 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SURGERY WHEN SURGEON WAS INSERTING CANNULATED SCREW WITH WASHER, THE WASHER BROKE IN HALF. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316228 ↗
• MalfunctionDec 20, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE TITANIUM WASHER BROKE WHEN TIGHTENING A TITANIUM CANNULATED SCREW IN THE SACRO-ILLIAC JOINT. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044633 ↗
• MalfunctionOct 1, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A WASHER BROKE DURING HIP SURGERY. IT WAS REPLACED WITH A NEW WASHER. ALL DEVICE FRAGMENTS WERE REMOVED. THIS REPORT IS FOR A WASHER 13.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562288 ↗
• MalfunctionMay 5, 2021Break; Break

  HOLD FOR JG 5.11IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PELVIC SURGERY PROCEDURE FOR UNKNOWN REASON. THE TITANIUM WASHER FOR 7.3MM CANNULATED SCREW BROKE DURING INSERTION. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN 7.3 CANNULATED SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) WASHER 13.0MM. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780049 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF NAIL DUE TO NONUNION AND DELAYED HEALING. ALL HARDWARE WAS INTACT. PATIENT WAS REVISED TO A PLATE. IT WAS NOTED THAT PATIENT HAD POOR BONE QUALITY AND FRACTURE PATTERN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8944780 ↗