STRATAFIX SXPP1B103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031236233), received between Nov 18, 2020 and Aug 25, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 25, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439603 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. DURING WOUND CLOSURE, THE NEEDLE COULD NOT BE PASSED THROUGH THE DERMIS SMOOTHLY DURING CONTINUOUS SUTURING. WHEN CHECKING THE NEEDLE TIP, IT WAS FOUND THAT THE NEEDLE TIP HAD BEEN BROKEN. IT IS UNKNOWN WHEN THE TIP WAS BROKEN. THE BROKEN NEEDLE TIP WAS TINY, AND IT DID NOT APPEAR ON THE X-RAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960665 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSABDOMINAL PREPERITONEAL SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE WAS INSERTED INTO THE PATIENT¿S BODY THROUGH A PORT WITHOUT BEING BENT. THEN, THE NEEDLE WAS BROKEN AT THE TIP WHEN SUTURING THE PERITONEUM UNDER A LAPAROSCOPE. THE BROKEN PIECE HAS NOT BEEN RETRIEVED. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10871849 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSABDOMINAL PREPERITONEAL SURGERY ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AT THE TIP WHILE SUTURING THE PERITONEUM BY CONTINUOUS SUTURING UNDER A LAPAROSCOPE. BEFORE THIS ISSUE OCCURRED, THE AFFECTED NEEDLE HAD BEEN INSERTED INTO THE PATIENT¿S BODY FROM THE PORT WITHOUT BEING BENT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10861083 ↗