Design Options® 560603Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964320842), received between Dec 21, 2016 and Jun 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 6, 2026Open, Classified

   These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

   Z-2278-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SPINAL NEEDLE BROKE OFF INSIDE PATIENT. DETAILED INQUIRY DESCRIPTION: ONE OF THEIR CRNA'S WAS PLACING A SPINAL IN A PATIENT PREOPERATIVELY AS NORMAL PRIOR TO A TOTAL KNEE REPLACEMENT. THIS CRNA IS EXPERIENCED IN SPINALS AND DIDN'T HAVE TO ROUGHLY MANEUVER THE NEEDLE AT ALL. NOTHING OUT OF THE ORDINARY. THIS CRNA THEN FELT THE SPINAL NEEDLE THAT WAS THROUGH THE INTRODUCER "GIVE WAY" AND SAW THAT THE SPINAL NEEDLE HAD BROKEN OFF AT THE HUB. DESCRIBE TYPE OF INTERVENTION: BOARD RUNNER PHYSICIAN ASSISTED WITH THE FULL REMOVAL (WITH THE OR RN GRABBING SOME NECESSARY SUPPLIES).

  Patient problems: Foreign Body In Patient

  MAUDE report 22366791 ↗
• MalfunctionMay 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: VERY LARGE SHARD OF GLASS WITHIN GLASS SYRINGE IN SPINAL TRAY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106982 ↗
• MalfunctionMay 22, 2024Break; Break

  ACCORDING TO THE CUSTOMER: ANESTHESIA REPORTED A NEEDLE BREAKING DURING A PROCEDURE ON (B)(6) 2024. REPORTEDLY A NEW TRAY WAS OPENED WITH NO INCIDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. REPORTED EVENT OCCURRED IN PREPARATION/BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371142 ↗
• MalfunctionMay 3, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAD A SPINAL NEEDLE BREAK OFF FROM THE HUB IN SURGERY WHILE ANESTHESIOLOGIST WAS POSITIONING THE NEEDLE. SURGEON HAD TO MAKE INCISION AND RETRIEVE NEEDLE WITH FORCEPS. SKIN SUTURED. GENERAL ANESTHESIA GIVEN. NO SPINAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16864591 ↗
• MalfunctionDec 21, 2016Material Fragmentation; Material Fragmentation

  AS REPORTED BY USER FACILITY: APPROXIMATELY 1 INCH OF SPINAL NEEDLE BROKE OFF IN THE PATIENT WHICH REQUIRED THE PATIENT TO RETURN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF NEEDLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6196046 ↗