NA SD310.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982003973), received between Sep 11, 2018 and Sep 11, 2018 — classified as 3 injuries.

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

• InjurySep 11, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT UNDERWENT SURGERY FOR A TRAUMA CASE WITH A BROKEN PELVIS. DURING THE SURGERY, FOUR (4) DRILL BITS WITH QUICK COUPLING BROKE AT THE EXACT SAME SPOT. THE SURGEON WAS GETTING AN UNKNOWN SCREW IN THE PELVIS AND DID NOT HAVE MANY CHANCES. SURGEON HAD TO RISK NOT GETTING PROPER FIXATION DUE TO THE DRILL BIT BREAKAGE. PATIENT HAD TO RECEIVE A DIFFERENT OPERATIVE PLAN. REPORTEDLY, FOUR DRILL BIT TIPS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 DRILL BIT WITH QUICK COUPLING/180MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7865151 ↗
• InjurySep 11, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT UNDERWENT SURGERY FOR A TRAUMA CASE WITH A BROKEN PELVIS. DURING THE SURGERY, FOUR (4) DRILL BITS WITH QUICK COUPLING BROKE AT THE EXACT SAME SPOT. THE SURGEON WAS GETTING AN UNKNOWN SCREW IN THE PELVIS AND DID NOT HAVE MANY CHANCES. SURGEON HAD TO RISK NOT GETTING PROPER FIXATION DUE TO THE DRILL BIT BREAKAGE. PATIENT HAD TO RECEIVE A DIFFERENT OPERATIVE PLAN. REPORTEDLY, FOUR DRILL BIT TIPS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 DRILL BIT WITH QUICK COUPLING/180MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7865150 ↗
• InjurySep 11, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT UNDERWENT SURGERY FOR A TRAUMA CASE WITH A BROKEN PELVIS. DURING THE SURGERY, FOUR (4) DRILL BITS WITH QUICK COUPLING BROKE AT THE EXACT SAME SPOT. THE SURGEON WAS GETTING AN UNKNOWN SCREW IN THE PELVIS AND DID NOT HAVE MANY CHANCES. SURGEON HAD TO RISK NOT GETTING PROPER FIXATION DUE TO THE DRILL BIT BREAKAGE. PATIENT HAD TO RECEIVE A DIFFERENT OPERATIVE PLAN. REPORTEDLY, FOUR DRILL BIT TIPS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 30 MINUTES SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.5 DRILL BIT WITH QUICK COUPLING/180MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7865143 ↗