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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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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Sources and updates

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