XIA IS2210XLPRecalls & reported problems
Stryker Corporation · Specialty Cannulated Tap · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327141900), received between Aug 29, 2016 and Jul 9, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Most reported problems
Device problems
- Break3
- Fracture3
- Material Integrity Problem2
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2018Break; Fracture; Fracture
DURING SURGERY, THE TIP OF THE TAP INSTRUMENT BROKE OFF AND WAS NOTICED POST-OPERATIVELY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7669804 ↗MalfunctionSep 26, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE SURGEON HAS BECOME ACCUSTOMED TO USING THE SPECIALITY INSTRUMENT AND WANTS A REPLACEMENT FOR THE BROKEN ONE. UPDATE: DISTAL TIP OF THE TAP BROKE OFF WITHIN PATIENT VERTEBRAL BODY, THE PIECE WAS LEFT IN THE PATIENT CAVITY.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 5978374 ↗MalfunctionAug 29, 2016Break; Fracture; Difficult to Remove; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT; DURING SURGERY, THE SURGEON USED THE TAP(4.5MM). DURING USING THE TAP 4.5MM, THE SURGEON FOUND THAT THE TIP OF TAP BROKE. THE SURGEON COULD NOT REMOVE THE BROKEN TIP OF TAP FROM THE PATIENT BONE. THERE WAS A MISTAKE IN THE CATALOG NUMBER IN THIS CASE, AND SALES REP WAS CHECKING IT.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 5912536 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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