NA 292.68Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982180803), received between Mar 18, 2021 and Jun 15, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED ON AN UNKNOWN DATE THAT AT ONE OF THEIR HOSPITALS THEY HAVE HAD AN PLETHORA OF TRAYS BEGIN PEELING. THE STERILE PROCESSING DEPARTMENT HAS TAKEN NOTE OF THIS AND FLAGS THE TRAYS AS BEING UNSTERILE AND UNABLE TO BE STERILIZED UNTIL TRAYS WERE REPLACED. HAVE ATTACHED THE SETS 6.5/7/3 CANNULATED SCREWS IN A QUANTITY OF 2. IN ADDITION TO THE CANNULATED SCREWS, THERE WERE MORE SETS IN THE FILE OF THIS COMPLAINT THAT WEREN'T ABLE TO BE ATTACHED. THE SETS INCLUDE: 2.4/2/7 VA DISTAL RADIUS, TFNA IMPLANTS X2, TFNA INSERTION , TFNA OPENING/LOCKING X2, ORTHOPAEDIC CABLE, 4.5 VA CONDY PLATES, 4.5 VA CONDY INSTR. & SCREWS X2, 4.5 VA CONDY AIMING INSTR. X2, LCP SMALL FRAGMENT X3, 2.7/3.5 VA ELBOW, AND LARGE EX-FIX X2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25509535 ↗
• InjuryAug 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE PUTTING SCREWS IN OVER TWO OF THE 2.8 WIRES, THEY PERFORATED THE FEMORAL HEAD. ON OF THE 7.3 80MM CANNULATED SCREWS ALSO PERFORATED THE HEAD. THE SCREW WAS BACKED OUT, AND A WASHER WAS PLACED TO KEEP IT FROM ENTERING THE LATERAL CORTEX. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17541899 ↗
• InjuryAug 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE PUTTING SCREWS IN OVER TWO OF THE 2.8 WIRES, THEY PERFORATED THE FEMORAL HEAD. ON OF THE 7.3 80MM CANNULATED SCREWS ALSO PERFORATED THE HEAD. THE SCREW WAS BACKED OUT, AND A WASHER WAS PLACED TO KEEP IT FROM ENTERING THE LATERAL CORTEX. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17541897 ↗
• MalfunctionJul 27, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE TRYING TO INSERT A 2.8 GUIDE WIRE INTO AN OLECRANON FRAGMENT, THE SURGEON WAS CONCERNED BECAUSE THE THREADED GUIDE PIN WAS TORQUING ON THE FRAGMENT. THE SURGEON SWITCHED TO A DRILL TIP GUIDE PIN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE SURGEON DID NOT NECESSARILY MAKE ANY ALLEGATIONS AGAINST THE GUIDE PIN. THERE WAS NO SURGICAL DELAY, AND THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT'S OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) 2.8 THRD GUIDE WIRE- TROCAR POINT 300. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404483 ↗
• MalfunctionMar 15, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP WHILE REPOSITIONING A SCREW INTRAOPERATIVELY, A 2.8 WIRE BECAME LODGED INSIDE A 6.5 CANNULATED SCREW. THE SURGICAL TECH SAID THE WIRE HAD BEEN BENT INTRA-OP SO THERE WAS NO ALLEGATION AGAINST THE PRODUCTS. THE WIRE WAS REMOVED AND A NEW WIRE WAS SELECTED AND SCREW WAS IMPLANTED. NO ADVERSE EVENTS OCCURRED. THERE WAS NO REPORTED SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO FRAGMENTS COMPLETED. IT WAS UNKNOWN IF WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.8 THIRD GUIDE WIRE- TROCAR POINT 300 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549818 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. PATIENT CURRENTLY NEEDS A COLOSTOMY BAG UNTIL HEALED. IT WAS ALSO REPORTED THAT THERE APPEARS TO BE SOMETHING WRONG WITH THE SCREW. UPON INSPECTION AFTER INSERTION (VIA X-RAY), IT APPEARS TO HAVE SOMETHING IN IT PREVENTING THE CANNULA FROM EASILY MOVING THROUGH. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520239 ↗