NA 6000-999-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540391933), received between Jun 28, 2018 and Mar 20, 2020 — classified as 23 malfunctions.

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

• MalfunctionMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, THE HOOK BROKE OFF THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILE PROCESSING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9861377 ↗
• MalfunctionMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, THE DEVICE WAS FOUND IN PIECES. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILE PROCESSING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9861293 ↗
• MalfunctionMar 20, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, THE THUMB KNOB WAS FOUND MISSING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILE PROCESSING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9861290 ↗
• MalfunctionMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, A SPRING WAS DISCOVERED TO BE MISSING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILE PROCESSING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9861289 ↗
• MalfunctionFeb 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE OFF DURING SET UP, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9694489 ↗
• MalfunctionOct 8, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CLAMP BROKE DURING SET UP, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9167060 ↗
• MalfunctionSep 9, 2019Break; Material Deformation; Break; Material Deformation

  THE CUSTOMER REPORTED THAT, DURING TESTING, IT WAS OBSERVED THAT THE UNIT IS STRIPPED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8976501 ↗
• MalfunctionSep 9, 2019Break; Material Deformation; Break; Material Deformation

  THE CUSTOMER REPORTED THAT, DURING TESTING, IT WAS OBSERVED THAT THE UNIT IS STRIPPED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8974944 ↗
• MalfunctionSep 3, 2019Unintended Ejection; Fracture; Unintended Ejection; Fracture

  THE CUSTOMER REPORTED THAT, DURING TESTING, THE DEVICE BROKE AND FLEW ACROSS THE ROOM. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8956761 ↗
• MalfunctionJul 25, 2019Unintended Ejection; Unintended Ejection

  THE CUSTOMER REPORTED THAT THE DEVICE SHOT ACROSS THE ROOM. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826344 ↗
• MalfunctionJul 25, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THE DEVICE WAS IN PIECES DURING A ROUTINE MAINTENANCE VISIT THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8826342 ↗
• MalfunctionJun 11, 2019Break; Break

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE HOOK BROKE OFF, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687839 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A COMPONENT OF THE DEVICE SNAPPED OFF. THE DEVICE'S COMPONENT HIT THE SURGEON IN THE HAND WHEN IT SNAPPED OFF CAUSING DISCOMFORT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596328 ↗
• MalfunctionFeb 21, 2019Break; Break

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIGHTENING SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357924 ↗
• MalfunctionNov 1, 2018Fracture; Fracture

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT A SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028033 ↗
• MalfunctionNov 1, 2018Fracture; Fracture

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT A SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028029 ↗
• MalfunctionNov 1, 2018Fracture; Fracture

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT A SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027983 ↗
• MalfunctionNov 1, 2018Fracture; Fracture

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT A SCREW WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027980 ↗
• MalfunctionOct 1, 2018Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING AFTER A PROCEDURE AT THE USER FACILITY THE DEVICE'S TOP WAS FOUND TO BE MISSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922196 ↗
• MalfunctionOct 1, 2018Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING AFTER A PROCEDURE AT THE USER FACILITY THE DEVICE'S TOP WAS FOUND TO BE MISSING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922128 ↗
• MalfunctionAug 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY THE DEVICE'S TOP WAS FOUND TO BE BROKEN OFF.   NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818791 ↗
• MalfunctionJul 17, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY THE UNIT WAS FOUND MISSING A PART. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693838 ↗
• MalfunctionJun 28, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE CONNECTION INSIDE OF THE NAVLOCK WAS SNAPPED IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645596 ↗