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FORCE FIBER IPN914069Recalls & reported problems

Teleflex Incorporated · White Blue UHMWPE Co-Braid size 2 Looped 20" GR51 Needle S&N · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34026704637530), received between Nov 8, 2021 and Jun 12, 2023 — classified as 3 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

Device problems

  • Break3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2023Break; Break

    IT WAS REPORTED THAT "DURING ACL PROCEDURE, EXTERNAL TO PATIENT, TWO SUTURES BROKE WHEN THE ASSISTANT WAS SUTURING THE GRAFT. BOTH SUTURES GOT DETACHED FROM THE NEEDLE WHEN SUTURING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED." ADDITIONAL INFORMATION STATES THAT THERE WAS NO PATIENT HARM OR INJURY. PER THE CUSTOMER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17111272 ↗
  • MalfunctionJun 12, 2023Break; Break

    IT WAS REPORTED THAT "DURING ACL PROCEDURE, EXTERNAL TO PATIENT, TWO SUTURES BROKE WHEN THE ASSISTANT WAS SUTURING THE GRAFT. BOTH SUTURES GOT DETACHED FROM THE NEEDLE WHEN SUTURING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED." ADDITIONAL INFORMATION STATES THAT THERE WAS NO PATIENT HARM OR INJURY. PER THE CUSTOMER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17111241 ↗
  • MalfunctionNov 8, 2021Break; Break

    IT WAS REPORTED THAT DURING ACL PROCEDURE, EXTERNAL TO PATIENT, TWO SUTURES BROKE WHEN THE ASSISTANT WAS SUTURING THE GRAFT. BOTH SUTURES GOT DETACHED FROM THE NEEDLE WHEN SUTURING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12774415 ↗

Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices

All SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices →

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