PDS D7460Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031027800), received between Apr 6, 2023 and Oct 15, 2025 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN CLOSING THE WOUND, THE SCRUB NURSE NOTICED THAT THE NEEDLE TIP WAS CHIPPED WHEN HOLDING IT BY THE NEEDLE HOLDER. A NEW PACKAGE WAS OPENED INSTEAD OF THE PACKAGE INVOLVED, BUT THE SAME CHIP WAS FOUND, AND THE 3RD PACKAGE WAS ABLE TO BE USED NORMALLY. THE LOT INVOLVED HAS BEEN SUSPENDED FROM USE ALONG WITH THE WHOLE BOX. IF A SIMILAR EVENT HAS BEEN OCCURRING WITH THE INVOLVED LOT, IT IS PLANNED TO RETRIEVE THE WHOLE BOX. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279619 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN CLOSING THE WOUND, THE SCRUB NURSE NOTICED THAT THE NEEDLE TIP WAS CHIPPED WHEN HOLDING IT BY THE NEEDLE HOLDER. A NEW PACKAGE WAS OPENED INSTEAD OF THE PACKAGE INVOLVED, BUT THE SAME CHIP WAS FOUND, AND THE 3RD PACKAGE WAS ABLE TO BE USED NORMALLY. THE LOT INVOLVED HAS BEEN SUSPENDED FROM USE ALONG WITH THE WHOLE BOX. IF A SIMILAR EVENT HAS BEEN OCCURRING WITH THE INVOLVED LOT, IT IS PLANNED TO RETRIEVE THE WHOLE BOX. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279601 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862606 ↗
• MalfunctionApr 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, WHEN THE NEEDLE WAS TAKEN OUT FROM THE PACKAGE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. UPON VISUAL ASSESSMENT OF THE RETURNED SUTURE, IT WAS OBSERVED THAT THE STRAND HAS BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THIS CONDITION CONTRIBUTES TO THE NEEDLES SEPARATING FROM THE SUTURES. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED DUE TO HANDLING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688530 ↗