NA 9200-10-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295221906), received between May 31, 2018 and Mar 5, 2026 — classified as 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (16 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

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Material Deformation; Scratched Material

  IT WAS REPORTED THAT DURING MANUFACTURER'S PRELIMINARY EXAMINATION OF THE DEVICE IT WA IDENTIFIED THAT THE HUDSON CONNECTION AREA AND POST WERE DEFORMED. ADDITIONALLY, DEVICE HAD SIGNS OF HEAVY USAGE ON ITS SURFACE, DELAMINATED PATTERNS ON THE CONNECTION EDGES. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520306 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED IN THE HUDSON CONNECTION AREA. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403303 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED IN THE HUDSON CONNECTION AREA. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403293 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED IN THE HUDSON CONNECTION AREA. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403246 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED IN THE HUDSON CONNECTION AREA. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403119 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED IN THE HUDSON CONNECTION AREA. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403105 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT ON INSPECTION, THERE WAS NOTED BREAKAGE OF AN ITEM IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714366 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT A DRIVER BROKE DURING HIP SURGERY. THE ATTACHMENT SPRING WAS BROKEN. THERE WAS NOTHING LEFT IN THE PATIENT, NOTHING BROKE IN TWO. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 21912625 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS REAMING WITH THE REAMER DRIVER AND THE INNER METAL CONNECTING PIECE BROKE OFF AND IS NO LONGER USABLE. IT WAS THOUGHT THAT THIS WAS DUE TO WEAR AND TEAR OVER TIME AS THE INSTRUMENT IS QUITE OLD. SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS ONLY A SHORT DELAY OF ONE MINUTE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873757 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE INSTRUMENT WOBBLES IN THE HUDSON CONNECTION (SEVERAL CONNECTIONS TRIED), AS A RESULT THE CUP REAMER IN THE ACETABULUM WOBBLES AND POSSIBLY LEADS TO A LARGER REAMING THAN INTENDED. IN ADDITION, THE INSTRUMENT HAS A PE PART THAT IS DIFFICULT TO REMOVE FROM THE ANCHORAGE FOR THE STERILE PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116003 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED THAT THE ANGLED REAMER DRIVER INSTRUMENT BROKE DURING HIP SURGERY. IT DID NOT BREAK INTO TWO, NOTHING WAS LEFT INSIDE THE PATIENT AND THERE WERE NO DELAYS TO SURGERY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725874 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Material Deformation; Mechanical Jam; Device-Device Incompatibility; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT AN OPTIMIS REAMER HANDLE WAS UNABLE TO LOCK; SURGICAL TEAM WAS UNABLE TO PROPERLY ASSEMBLE THE HANDLE DURING OP SETUP. THEY WERE UNABLE TO ASSEMBLE IT CORRECTLY DUE TO THE PIN GETTING STUCK. IT SEEMS TO HAVE BENT OUT OF SHAPE OR IS JAMMING AND IS NOT IN USABLE CONDITION WITHOUT REPAIRS. THIS WAS NOTICED IMMEDIATELY AFTER OPENING THE LOAN TRAY BEFORE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677727 ↗
• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DSI HANDLE DOES NOT GRIP THE REAMER, KEEPS FALLING OFF NEEDS REPLACING. THERE WAS NO PATIENT CONSEQUENCE OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891530 ↗
• MalfunctionJul 13, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SPRING MECHANISM WHICH ENABLES THE ATTACHMENT OF A CUP OR CUP TRIAL IS DEFECTIVE. USUALLY, THIS IS DUE TO THE SPRING COMING AWAY FROM IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316163 ↗
• MalfunctionJun 29, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HUDSON CONNECTION IS WORN. IT IS GENERATING METAL WEAR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852129 ↗
• MalfunctionMay 20, 2022Break; Break

  INSTRUMENT BROKE DURING HIP SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464395 ↗
• MalfunctionDec 28, 2021Break; Crack; Break; Crack

  TWO OF THE PRIMARY ACETABULAR HANDLES CRACKED. THE BLACK ATTACHMENT THAT TURNS INSTRUMENT ALSO CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094933 ↗
• MalfunctionDec 28, 2021Break; Crack; Break; Crack

  TWO OF THE PRIMARY ACETABULAR HANDLES CRACKED. THE BLACK ATTACHMENT THAT TURNS INSTRUMENT ALSO CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094856 ↗
• MalfunctionAug 17, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE OPTIMIS REAMER WOULD NOT CONNECT TO THE HUDSON ADAPTOR. TRIED MULTIPLE DIFFERENT HUDSON ADAPTORS. IT APPEARS THE CONNECTION HAS BEEN WORN. THERE WAS A TWO MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330445 ↗
• MalfunctionJul 28, 2021Break; Crack; Naturally Worn; Break; Crack; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT INSERTERS DID NOT BREAK AND THE PLASTIC PART OF THE HANDLE BROKE/CRACKED AND THEREFORE CANNOT BE STERILIZED PROPERLY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242688 ↗
• MalfunctionApr 28, 2021Material Integrity Problem; Material Integrity Problem

  WHEN REAMING THE ACETABULUM THE SHAFT OF THE INSTRUMENT IS GETTING REALLY HOT. NOTHING BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736923 ↗
• MalfunctionApr 28, 2021Material Integrity Problem; Material Integrity Problem

  WHEN REAMING THE ACETABULUM THE SHAFT OF THE INSTRUMENT IS GETTING REALLY HOT. NOTHING BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736922 ↗
• MalfunctionJan 22, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE INSTRUMENT´S CONNECTION TO THE HUDSON ADAPTER IS WORN. IT DOES NOT HOLD ANY LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216330 ↗
• MalfunctionJan 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  COMPLAINT REGARDING AN ANGLED REAMER PRODUCT REF 920010031 AND LOT NUMBER MJ3666601. CONSISTS OF 3 PARTS WHEN DISASSEMBLED FOR CLEANING. THE INSTRUMENT CHECKED YESTERDAY AND COULD NOT REASSEMBLE IT, NEITHER COULD SSD. THE REAMER ARM WILL NOT SIT WITHIN THE HANDLE. WHEN COMPARED TO ANOTHER FUNCTIONAL ONE THE REAMER ATTACHMENT AT THE DISTAL TIP DOESN¿T SEEM TO SIT AS FLUSH WHICH COULD BE THE REASON WHY. IT WAS LAST USED FOR A CASE ON MONDAY 4TH JAN AND REPORTER WASN¿T MADE AWARE OF ANY ISSUES WITH IT SO NOT AWARE OF ANY DELAYS TO SURGERY, JUST AN ISSUE POST-SURGERY WITH STERILE SERVICES DEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185552 ↗
• MalfunctionDec 9, 2020Material Twisted/Bent; Material Twisted/Bent

  SURGEON EXPERIENCED DIFFICULTY USING REAMER. REPORTED THAT HE SUSPECTED A COMPONENT HAD BECOME WARN AND REQUIRED REPLACEMENT, DUE TO INCREASE OF TORQUE FORCES EXPERIENCED DURING REAMING PROCESS. DISTAL PART OF SHAFT MECHANISM SEEMED STIFF. OPERATION COMPLETED WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975694 ↗