NA SD393.640Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982006608), received between Sep 24, 2019 and Sep 19, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE RECENTLY, AN ORDER WAS PLACED FOR 2 DISTRACTORS. ONE OF THE TWO DISTRACTORS CENTRAL BORE WAS NOT LARGE ENOUGH TO FIT AN 11MM ROD AS INTENDED. THIS ITEM WAS IDENTIFIED DURING PRE-OP TESTING AND DID NOT IMPACT PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255050 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES CONSULTANT FOUND A COUPLE BROKEN INSTRUMENTS. THE SALES ASSOCIATE WAS UNSURE AS TO HOW OR WHEN THE INSTRUMENTS BROKE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18702780 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A PRODUCT WAS BROKEN DURING AN OPEN REDUCTION/INTERNAL FIXATION SURGERY. THE BROKEN PRODUCT WAS REMOVED, AND THE SURGEON USED A WORKING PRODUCT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A TWO-MINUTE DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE DISTRACTOR FOR 11MM ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275710 ↗
• MalfunctionNov 29, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LINEAR DISTRACTOR ARM WAS DAMAGED, MAYBE CROSS THREADED AND POSSIBLY BENT AS WELL. IT WOULD NOT THREAD TOGETHER, MAKING IT UNUSABLE. ANOTHER LESS DESIRABLE ARM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF FIVE MINUTES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DISTRACTOR FOR 11MM ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226620 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER ITEM NUMBER 314.05 HANDLE BROKE APART AT STERILE PROCESSING 4.0MM HEXAGONAL SCREWDRIVER AND TWO DISTRACTOR ITEM NUMBER SD393.640 DID NOT TIGHTEN AND BROKEN ACROSS. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507399 ↗
• MalfunctionDec 23, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER A CASE ONE OF THE BOLTS WAS OFF ITS THREADS AND UPON TRYING TO LOOSEN THE BOLT IT STRIPPED THE THREADS. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042459 ↗
• MalfunctionApr 16, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NUTS ON TWO (2) DISTRACTORS WERE COLD-WELDED. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682004 ↗
• MalfunctionApr 16, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NUTS ON TWO (2) DISTRACTORS WERE COLD-WELDED. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681975 ↗
• MalfunctionNov 11, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STERILE PROCESSING DEPARTMENT (SPD) GAVE A DISTRACTOR TUBE WITH A BROKEN BOLT. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR A DISTRACTOR FOR 11 MM ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822743 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) DISTRACTOR WAS BROKEN AT THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10012215 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) DISTRACTOR WAS BROKEN AT THE STERILE PROCESSING DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11MM ROD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10012210 ↗
• MalfunctionApr 6, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2020, THE DISTRACTOR FOR 11 MM ROD HAS A SCREW ON THE CLAMP ASPECT OF THE DEVICE THAT GOT CROSS-THREADED AND USED TO SCREW AND RENDERING IT USELESS. IT IS UNKNOWN IF THERE WAS PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11 MM ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930772 ↗
• InjuryNov 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE CALCANEUS A SCREW OF A DISTRACTOR FOR AN 11 MM ROD WAS TOO BIG AND CROSS-THREADED CAUSING IT TO BE UNUSABLE. THE INTENDED FRAME REQUIRED BILATERAL DISTRACTORS TO BE USED SYNONYMOUSLY. WITH ONE OF THE TWO ON HAND BROKEN THE INTENDED DISTRACTOR FRAME WOULD NOT BE ABLE TO DISTRACT IN A UNIFORM MANNER. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED BY MANUAL DISTRACTION USING A LARGE EXTERNAL FIXATOR FRAME. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) DISTRACTOR FOR 11 MM ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9357419 ↗
• MalfunctionSep 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2019, THAT THE DISTRACTOR FOR ROD CONNECTION CLAMP WAS FOUND OUT BENT, UPON INSPECTION BY STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9112543 ↗
• MalfunctionSep 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2019, THAT THE DISTRACTOR FOR ROD CONNECTION CLAMP WAS FOUND OUT BENT, UPON INSPECTION BY STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9112539 ↗