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N/A OM-9620Recalls & reported problems

Smith & Nephew, Inc. · 5.5 MM PUNCH TAP REUSABLE · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470002591), received between Jul 26, 2022 and Jul 26, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

  • InjuryJul 26, 2022Break; Break

    IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHILE THE PUNCH TAP WAS PUNCHED INTO THE BONE, IT BROKE OFF. THE BROKEN PIECES WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. ACCORDING TO THE SURGEON, IT WAS A NORMAL BONE QUALITY. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15106260 ↗

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Sources and updates

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