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Henry Schein 5700464Recalls & reported problems

Henry Schein, Inc. · Suture PGA PCL Mono DSM13 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040039595), received between Mar 10, 2022 and Mar 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2022Break

    THE DOCTOR WAS PERFORMING AN EXCISION PROCEDURE OF MELANOMA WITHIN THE ABDOMEN OF A PATIENT, NO SPECIFICS PROVIDED WHEN THE NEEDLE ITSELF BROKE AND AWAY FROM THE SUTURE. THE NEEDLE FELL INTO THE SITE WHERE THE DOCTOR WAS SUTURING BUT THE PATIENT WAS NOT HARMED OR REQUIRED ANY MEDICAL ATTENTION. THE TECHNIQUE THE DOCTOR USES IS NOT KNOWN HOWEVER, THEY DID PROVIDE A PHOTO OF THE BROKEN SUTURE. THE DOCTOR USES NEEDLE DRIVER AND PICKUPS WHILE SUTURING. THE PIECE WAS RETRIEVED. THE DOCTOR ALSO MENTIONED THAT THE NEEDLE BROKE AFTER THREE THROWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13727595 ↗

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

All SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.