COMPRESSION SLEEVE 5032-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848665036480), received between Jun 19, 2024 and May 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 14, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: DURING A TROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE, THE COMPRESSION WHEEL AND INSERTER HANDLE FAILED TO PROVIDE PROPER COMPRESSION, EXHIBITING SLIPPING OR CLICKING AT A CERTAIN POINT WHEN ATTEMPTING TO COMPRESS. THIS ISSUE HAD PREVIOUSLY BEEN OBSERVED IN THREE CASES INVOLVING TROCH NAILS, THOUGH SPECIFIC DATES OR CASE DETAILS ARE UNAVAILABLE. WHILE THE ISSUE DID NOT IMPACT THE CASES OR PATIENTS, A RECURRING PATTERN WAS LATER IDENTIFIED. THE CASE WAS COMPLETED IN STANDARD FASHION, ACHIEVING AS MUCH COMPRESSION AS THE INSTRUMENT ALLOWED WITHOUT REQUIRING ADDITIONAL PRODUCTS. THERE WAS NO REPORTED DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AFFECTED PRODUCTS, IN THIS CASE, INCLUDED THE LAG SCREW INSERTER AND COMPRESSION WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017965 ↗
• MalfunctionMay 14, 2025Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/07/2025: DURING A TROCHANTERIC NAIL PROCEDURE ON AN UNKNOWN DATE, THE COMPRESSION WHEEL AND INSERTER HANDLE FAILED TO PROVIDE PROPER COMPRESSION, EXHIBITING SLIPPING OR CLICKING AT A CERTAIN POINT WHEN ATTEMPTING TO COMPRESS. THIS ISSUE HAD PREVIOUSLY BEEN OBSERVED IN THREE CASES INVOLVING TROCH NAILS, THOUGH SPECIFIC DATES OR CASE DETAILS ARE UNAVAILABLE. WHILE THE ISSUE DID NOT IMPACT THE CASES OR PATIENTS, A RECURRING PATTERN WAS LATER IDENTIFIED. THE CASE WAS COMPLETED IN STANDARD FASHION, ACHIEVING AS MUCH COMPRESSION AS THE INSTRUMENT ALLOWED WITHOUT REQUIRING ADDITIONAL PRODUCTS. THERE WAS NO REPORTED DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AFFECTED PRODUCTS, IN THIS CASE, INCLUDED THE LAG SCREW INSERTER AND COMPRESSION WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017963 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Material Fragmentation

  ON 10/25/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 5032-000 COMPRESSION SLEEVE'S RUBBER "O" RING MADE ITS WAY OUT WHEN THE "LEFTY" LAG SCREW WAS INSERTED. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2021. SURGEON WAS ABLE TO COMPLETE PROCEDURE WITHOUT THE "O" RING AND ASSURED THE LAG SCREW WAS INSERTED WITH GREAT COMPRESSION FUNCTION. DURING INSPECTION OF THE COMPRESSION SLEEVE AFTER THE CASE, IT WAS DETERMINE THAT THE "O" RING APPEARED TO BE CUT IN TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567592 ↗