ARTHRO-PIERCE 72202683Recalls & reported problems
Smith & Nephew, Inc. · ARTHRO-PIERCE XL STRAIGHT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010651457), received between Jan 17, 2018 and Dec 29, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, AFTER PLACING THE ANCHOR, THE DOCTOR USED A LARGE ARTHROPIERCE TO PASS THE WIRE THROUGH THE LABRUM, IT BECAME ENTANGLED IN THE TISSUE AND BROKE, RELEASING THE PIECE INTO THE PATIENT'S JOINT. A FEW MINUTES LATER, THE DOCTOR MANAGED TO FIND AND REMOVE THE ENTIRE BROKEN PIECE USING GRASPER FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23915594 ↗MalfunctionDec 3, 2024Break; Break
IT WAS REPORTED THAT DURING A HIP SURGERY, WHEN THE ARTHROPIERCE XL STRAIGHT WAS PULLED BACK THE TOP METAL LEVER BROKE OFF. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20838895 ↗MalfunctionFeb 23, 2022Break; Break
IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN CHECKING THE DEVICE IN INSTRUMENTATION TABLE, THE DISTAL PORTION OF THE ARTHROPIERCE WAS BENT TO THE LEFT AND THE TIP WAS BROKEN OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY SURGICAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13585560 ↗MalfunctionMar 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, THE ARTHRO-PIERCE XL CLIPPER DISASSEMBLED AT THE MOMENT THAT THE SURGEON HANDLED HAND BEFORE ENTERING THE PATIENT'S JOINT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11528006 ↗MalfunctionNov 5, 2018Break
IT WAS REPORTED THAT WHEN THE TWEEZERS WERE USED TO PULL THE ANCHOR, THE WIRE TIP BROKE. TIP WAS REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8040025 ↗MalfunctionAug 18, 2018Positioning Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT TIP OF THE DEVICE WAS MISALIGNED. WHEN SOFT TISSUE PIERCED, IT GOT STUCK AND COULD NOT COME OFF DUE TO THE MISALIGNED ISSUE. AS PER CUSTOMER REPORT, NO PATIENT INJURY WAS REPORTED. PROCEDURE WAS FINISHED WITH THE SAME DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7795970 ↗MalfunctionJan 17, 2018Break
IT WAS REPORTED THAT THE DEVICE WAS CUTTING AND BREAKING THE SUTURES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7202563 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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