NA 72200082Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010541529), received between Jan 8, 2018 and Oct 2, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 5.5MM BURR WAS SHEDDING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES REMOVED BY SUCTION THROUGH SHAVER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352434 ↗
• InjuryOct 4, 2022Break; Break

  IT WAS REPORTED THAT ON CLINICAL STUDY "HIP ARTHROSCOPY SAFETY AND EFFECTIVENESS REPORT: ACCU-PASS DIRECT CRESCENT XL, CAP-FIX BLADE, HIP PACK, CLEAR TRAC CANNULA, 5.5MM ABRADER BURR, AND 4.5MM CURVED FULL RADIUS SHAVER", WAS FOUND THAT DURING HIP CAPSULE CLOSURE AND HIP LABRAL REPAIR PROCEDURES, A 5.5MM ABRADER BURR WAS NOTED TO BE SPITTING METAL AFTER SIGNIFICANT ACETABULOPLASTY. BURR WAS REMOVED AND FRAGMENTS WERE EVACUATED FROM THE JOINT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536500 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY 8 PATIENTS HAD EXTENSIVE CHONDRAL DAMAGE REQUIRING CONVERSION TO TOTAL HIP ARTHROPLASTY. PAPER INDICATES THAT SMITH&NEPHEW BURR 5.5MM ABRADER WAS USED, HOWEVER, NO MALFUNCTION WAS REPORTED DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447182 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY 2 PATIENTS HAD CAPSULAR ADHESIONS REQUIRING REVISION SURGERY. PAPER INDICATES A BURR DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: Capsular Contracture

  MAUDE report 12436750 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY PATIENT HAD REVISION FOR RESIDUAL CAM CORRECTION. PAPER INDICATES THAT SMITH&NEPHEW DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 12436515 ↗
• InjuryMay 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR, WHEN THE ABRADER BURR WAS USED, METAL FILLINGS WERE DISBURSED EVERYWHERE ONCE ENGAGED. MOST OF THE FILLINGS WERE REMOVED BY SUCTION AND LAVAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11773766 ↗
• MalfunctionJun 29, 2018Unintended Ejection

  IT WAS REPORTED THAT DURING A HIP SCOPE THE BURR USED STARTED SPITTING OUT BLUE STUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651737 ↗
• MalfunctionJun 29, 2018Unintended Ejection

  IT WAS REPORTED THAT DURING A HIP SCOPE THE BURR USED STARTED SPITTING OUT BLUE STUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651726 ↗
• MalfunctionApr 20, 2018Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE WAS SHEDDING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446021 ↗
• MalfunctionJan 8, 2018Metal Shedding Debris

  IT WAS REPORTED THAT THE METAL PARTS OF THE BURR WAS LEFT IN THE JOINT OF THE PATIENT. ONLY SOME SHARDS WERE ABLE TO BE REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7172939 ↗