NA 03.118.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982073327), received between Oct 29, 2019 and Oct 23, 2024 — 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 18, 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.

• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE SALES REPRESENTATIVE NOTICED THAT SEVERAL WERE DAMAGED. IT IS UNKNOWN WHEN THE INSTRUMENTS WERE DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AFFECTED PRODUCTS ARE: 1. DISTRACTOR: THERE IS A SPRING TECH DEVICE IN THE HANDLE, AND THAT SPRING DEVICE IS BROKEN. 2. DEPTH GAUGE: BENT AND UNABLE TO BE USED. 3. POWER ADAPTER FOR SCHANTZ PINS: STRIPPED AND UNABLE TO HOLD THE PIN IN IT. 4. TENSION HOLDER FOR THE CABLE SET (3X): WILL NOT HOLD THE ATTACHMENT BIT FOR THE TENSION HOLDER ANY LONGER. 5.ATTACHMENT BIT (3X): THE TIPS OF THESE WERE BENT IN; THE CABLE WAS UNABLE TO GO THROUGH IT. 6. HANDLE QUICK COUPLING (2X): THE RUBBER ON THE HANDLE WAS CUT AND NOT ALLOWING THE HANDLE TO BE CLEANED PROPERLY. 7. T25 SCREWDRIVER (2X): THE TIP WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513875 ↗
• MalfunctionDec 8, 2022Break; Break

  IT WAS REPORTED ON UNKNOWN DATE, THAT THE FORCEPS SPEED LOCK FROM A CONSIGNMENT SET, HAD BROKEN. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) LARGE DISTRACTION FORCEPS SPEED LOCK THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939484 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(6) SITE ON AN UNKNOWN DATE, THE LARGE DISTRACTION FORCEPS WITH SPEED LOCK WAS BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) LARGE DISTRACTION FORCEPS WITH SPEED LOCK. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11323169 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, THE HANDLE OF THE LARGE DISTRACTION FORCEPS WITH SPEED LOCK SET WAS NOTICED TO BE BROKEN AT SACRED HEART MEDICAL CENTER (SHMC) ORTHO STATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252420 ↗