TELEFLEX IPN056736Recalls & reported problems
Teleflex Incorporated · UHMWPE size 5 white/blue multicolor braid 1 needle 40" Smith and Nephew · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34026704735250), received between Jan 28, 2025 and Jan 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Break; Break
IT WAS REPORTED THAT: "DURING AN UNSPECIFIED PROCEDURE, TWO (2) ULTRABRAID SUTURES BROKE WHEN PUT UNDER TENSION. THE PROCEDURE WAS COMPLETED BY MODIFYING THE PROTOCOL AND USING SUTURES WITH AN OLDER TECHNIQUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED". NO REPORT OF PATIENT HARM OR INJURY. SEE ASSOCIATED MDR# 3004365956-2025-00002.
Patient problems: Insufficient Information
MAUDE report 21254441 ↗MalfunctionJan 28, 2025Break; Break
IT WAS REPORTED THAT: "DURING AN UNSPECIFIED PROCEDURE, TWO (2) ULTRABRAID SUTURES BROKE WHEN PUT UNDER TENSION. THE PROCEDURE WAS C OMPLETED BY MODIFYING THE PROTOCOL AND USING SUTURES WITH AN OLDER TECHNIQUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED". NO REPORT OF PATIENT HARM OR INJURY. SEE ASSOCIATED MDR# 3004365956-2025-00001.
Patient problems: Insufficient Information
MAUDE report 21254413 ↗
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- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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