NA 298.800.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982182494), received between May 31, 2019 and Jun 4, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A CABLE SNAPPED UNDER A MAXIMUM OF 40 KG TENSION. THE SECOND CABLE BEGAN FRAYING AT THE CRIMP BEFORE TENSION WAS ACHIEVED THEREFORE RENDERING IT UNUSABLE. BOTH CABLES WERE COMPLETELY REMOVED AND WERE REPLACED WITH NEW ONES. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8666941 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS TENSIONING A 1.0 MM CABLE DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF HIP FRACTURE, THE CABLE WITH CRIMP BROKE. CABLE WAS REMOVED AND REPLACED WITH AN UNKNOWN 1.7 MM CABLE. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - TENSIONING INSTRUMENTS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 1.0 MM CABLE WITH CRIMP 750 MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8659092 ↗