Tools - Screws PEG-XTNDRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842188112867), received between Dec 20, 2017 and Feb 9, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Corroded” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2018Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2018, IT WAS REPORTED, BY A TRIMED SALES REP, THAT A PEG-XTNDR IN HIS SET WERE SHOWING RUST AROUND THE SPRING. THE REP REPORTED THAT THIS FEEDBACK WAS NOT ASSOCIATED WITH A CLINICAL EVENT, AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SIXTH COMPLAINT OF THIS KIND FOR THIS TYPE OF PART.

  Patient problems: No Patient Involvement

  MAUDE report 7261847 ↗
• MalfunctionFeb 9, 2018Material Integrity Problem; Material Integrity Problem

  ON JANUARY 11, 2018, IT WAS REPORTED, BY A TRIMED SALES REP, THAT A PEG-XTNDR IN HIS SET WERE SHOWING RUST AROUND THE SPRING. THE REP REPORTED THAT THIS FEEDBACK WAS NOT ASSOCIATED WITH A CLINICAL EVENT, AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SIXTH COMPLAINT OF THIS KIND FOR THIS TYPE OF PART.

  Patient problems: No Patient Involvement

  MAUDE report 7261846 ↗
• MalfunctionDec 20, 2017Corroded; Device Inoperable

  DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN CHILE. THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF (B)(4) % BASED ON SALES SINCE 2010.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136685 ↗
• MalfunctionDec 20, 2017Corroded

  DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN CHILE. THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF (B)(4) BASED ON SALES SINCE 2010.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136682 ↗
• MalfunctionDec 20, 2017Corroded

  DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN CHILE. THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF 0.24% BASED ON SALES SINCE 2010.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136680 ↗
• MalfunctionDec 20, 2017Corroded

  DURING VISUAL REVIEW OF MATERIAL BEING SENT TO HOSPITAL, IT WAS DISCOVERED THAT THE SPRING ON A PEG-XTNDR HAD CORRODED. THE NON-CONFORMING PART WAS RETURNED TO THE DISTRIBUTOR, AT WHICH POINT THE DISTRIBUTOR NOTIFIED TRIMED OF THE COMPLAINT ON (B)(6) 2017. THIS INCIDENT OCCURRED IN (B)(6). THIS TYPE OF MALFUNCTION FOR THIS PART HAS AN OCCURRENCE RATE OF (B)(4) BASED ON SALES SINCE 2010.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7136679 ↗