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XIA 4.5 48130100Recalls & reported problems

Stryker Corporation · ROD ROTATION FORCEPS · 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 07613327264432), received between Jun 27, 2018 and Jun 27, 2018 — 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
  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 27, 2018Break; Fracture; Fracture

    IT WAS REPORTED THAT WHILE TURNING THE ROD, THE ROTATION KEY AND FORCEPS BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ALTERNATE TOOLS IN THE SURGERY ROOM. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7642887 ↗

Other INSTRUMENT, SURGICAL, NON-POWERED devices

All INSTRUMENT, SURGICAL, NON-POWERED devices →

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