NA 7209874Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010529596), received between Oct 9, 2017 and Jan 13, 2026 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A HIP PAC NITINOL WIRE BROKE MID-SURGERY. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058972 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A HIP SCOPE, WHEN TRYING TO ACCESS THE HIP JOINT THE DOCTOR PLACED THE HIP SCOPE DILATOR OVER THE HIP PAC DISPOSABLE 1.2MM GUIDE WIRE AND WAS TRYING TO PUSH IT THROUGH THE HIP CAPSULE. THE DILATOR AND THE FORCE APPLIED BROKE THE GUIDE WIRE. A 10CM WIRE WAS BROKEN OFF IN AND JUST OUT OF THE HIP JOINT. A SMALL 4CM INCISION WAS MADE IN THE SKIN AND TISSUE WAS DISSECTED DOWN TO THE HIP JOINT. THE REMNANT OF THE WIRE PROTRUDING FROM THE CAPSULE WAS GRASPED AND REMOVED FROM THE HIP JOINT WITH FINE NEEDLE NOSED PLIERS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: Perforation

  MAUDE report 23414085 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE NITINOL WIRE OF THE HIP DISPOSABLE PACK BROKE DURING THE ACCESS PORTION OF THE PROCEDURE. THE WIRE BROKE OFF IN THE PATIENT'S HIP AND THE PIECE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR ARTHREX BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150007 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HIP PAC´S GUIDEWIRE SNAPPED OFF UPON CONTACT WITH THE BONE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024958 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE NITINOL GUIDEWIRE ON THE DISPOSABLE HIP PAC BROKE WHEN INSERTING TO THE HIP; THE BROKEN WIRE WAS STUCK ON THE HIP. 5 CM OF THE WIRE WAS REMOVED FROM INSIDE THE PATIENT USING NEEDLE HOLDERS AND NO OTHER PIECES WERE LEFT INSIDE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332880 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, PART OF THE GUIDE WIRE ON THE DISPOSABLE HIP PAC BROKE OFF. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE TO AN OPEN PROCEDURE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236435 ↗
• InjuryFeb 24, 2022Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, ONE OF THE GUIDE WIRES OF THE HIP PACK DISPOSABLE SNAPPED OFF INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13594236 ↗
• 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 DISPOSABLE HIP PAC WAS USED, HOWEVER, NO MALFUNCTION WAS REPORTED DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447207 ↗
• 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 HIP PAC DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: Capsular Contracture

  MAUDE report 12436755 ↗
• 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 12436540 ↗
• 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, ONE PATIENT HAD REVISION FOR ILIOTIBIAL BAND RELEASE. PAPER INDICATES SMITH&NEPHEW DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436382 ↗
• MalfunctionJul 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING A DISPOSABLE HIP PAC KIT, ONE OF THE GUIDE WIRE WAS PLACED OVER THE CANNULA, AFTER THAT THE GUIDE WIRE BROKE WHILE THE OBRTURATOR WAS BEING ADVANCED SO IT WAS USED ANOTHER NEW GUIDE WIRE FROM THE SAME HIP KIT AND IT ALSO BROKE. ALL THE BROKEN WIRES WERE SUCCESSFULLY REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311999 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT ONE OF THE GUIDEWIRES SNAPPED OFF DURING SURGERY. ALL THE PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492012 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY 1 NITINOL GUIDEWIRE BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED WITH A GRASPER, THE SECOND ONE WORKED WITHOUT ANY PROBLEMS. THERE WAS A DELAY OF 10 MINUTES NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9152587 ↗
• MalfunctionApr 2, 2019Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GUIDE PIN BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS ATTEMPTED TO BE REMOVED ARTHROSCOPICALLY BUT ENDED UP BY OPENING. THIS CAUSED A DELAY GREATER THAN AN HOUR. NO OTHER PATIENT INJURY WAS REPORTED AND THE SURGEON WAS ABLE TO CONTINUE THE CASE WITH A DIFFERENT GUIDE PIN WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475265 ↗
• MalfunctionNov 13, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE GUIDE WIRE SNAPPED UPON INSERTION THROUGH CAPSULE. THE DEVICE BREAK INSIDE THE PATIENT AND WAS NOT REMOVED. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8064525 ↗
• MalfunctionApr 12, 2018Failure To Adhere Or Bond; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE IS NOT USABLE, THE BORDER DOESN'T STICK AND OPENS WHILE USING ARTICLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425832 ↗
• MalfunctionOct 9, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE GUIDE WIRE SNAPPED OFF IN THE TISSUE SURROUNDING THE CAPSULE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6933282 ↗