NA 03.118.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982073396), received between Apr 21, 2021 and Apr 21, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, FOUR OLIVE TIP WIRES BROKE, FOUR PLATE BENDERS WERE USED, AND CEMENT HAS STAINED THE BENDERS. DRILL BIT WAS USED OVER WIRE FOR A SCREW, AND DRILL BIT WAS BENT. SCREW CADDY MEASURING TAB BROKE OFF DURING SURGERY WHEN TRAY WAS DROPPED ON SCREW CADDY. THE SURGERY WAS DELAYED FOR 4 MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). UNKNOWN CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.8 COMP WIRE TEN (10) THREAD/200 LENGTH. THIS REPORT IS 4 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702232 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, FOUR OLIVE TIP WIRES BROKE, FOUR PLATE BENDERS WERE USED, AND CEMENT HAS STAINED THE BENDERS. DRILL BIT WAS USED OVER WIRE FOR A SCREW, AND DRILL BIT WAS BENT. SCREW CADDY MEASURING TAB BROKE OFF DURING SURGERY WHEN TRAY WAS DROPPED ON SCREW CADDY. THE SURGERY WAS DELAYED FOR FOUR (4) MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). UNKNOWN CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.8MM COMPRESSION WIRE 10MM THREAD/200MM LENGTH. THIS REPORT IS 3 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702229 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, FOUR OLIVE TIP WIRES BROKE, FOUR PLATE BENDERS WERE USED, AND CEMENT HAS STAINED THE BENDERS. DRILL BIT WAS USED OVER WIRE FOR A SCREW, AND DRILL BIT WAS BENT. SCREW CADDY MEASURING TAB BROKE OFF DURING SURGERY WHEN TRAY WAS DROPPED ON SCREW CADDY. THE SURGERY WAS DELAYED FOR 4 MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). UNKNOWN CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.8MM COMPRESSION WIRE 10MM THREAD/200MM LENGTH. THIS REPORT IS 2 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702227 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, FOUR OLIVE TIP WIRES BROKE, FOUR PLATE BENDERS WERE USED, AND CEMENT HAS STAINED THE BENDERS. DRILL BIT WAS USED OVER WIRE FOR A SCREW, AND DRILL BIT WAS BENT. SCREW CADDY MEASURING TAB BROKE OFF DURING SURGERY WHEN TRAY WAS DROPPED ON SCREW CADDY. THE SURGERY WAS DELAYED FOR 4 MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). UNKNOWN CEMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 2.8MM COMPRESSION WIRE 10MM THREAD/200MM LENGTH. THIS REPORT IS 1 OF 4 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702226 ↗