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NA 698337342Recalls & reported problems

Depuy Spine, LLC · MODIFIED INSTRUMENT TAP 5.5mm · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034376721), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 9, 2021Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION SURGERY A LARGE PATIENT WITH HARD BONE REQUIRED A GREAT DEAL OF TORQUE ON INSTRUMENTATION. TIPS OF THREE INSTRUMENTS BROKE DURING A CASE WITH A PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN ONE (1) MINUTE. FRAGMENTS WERE GENERATED AND EASILY REMOVED. PATIENT STATUS IS UNKNOWN. REPLACEMENT INSTRUMENTS IMMEDIATELY AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT PRODUCT REPORTED: MOD 5.5 TAP. MOD CURVED PROBE. EXPEDIUM SI POLY-DRIVER ASSY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MOD 5.5 TAP THIS REPORT IS 1 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11301176 ↗

Other TAP, BONE devices

All TAP, BONE devices →

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