NA 112240Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848486002930), received between Oct 2, 2018 and Apr 24, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Corroded; Difficult to Insert; Residue After Decontamination; Corroded; Difficult to Insert; Residue After Decontamination

  ITEMS WERE ¿RUSTED¿ AND UNABLE TO TIGHTEN. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793604 ↗
• MalfunctionMar 16, 2020Material Frayed; Material Frayed

  ON (B)(6) 2020 AT (B)(6) HEALTH CARE, A SURGICAL TECHNICIAN LOOSENED THE SIDE PIECE OF THE ARRAY WITH HER FINGERS TO DISSEMBLE IT DURING CLOSING ON THE BACK TABLE. DURING THIS, A SMALL SPLINTER OF METAL POKED THROUGH HER GLOVE AND PIERCED HER FINGER. THE METAL SPLINTER WAS TAKEN OUT AND SHE WAS SENT FOR BLOODWORK. THE DEFECTIVE PIECE WAS STERILIZED AND WILL BE SENT BACK FOR A REPLACEMENT. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 9837060 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Misassembled; Use of Device Problem; Misassembly by Users; Mechanical Problem; Misassembled; Use of Device Problem; Misassembly by Users

  PELVIC ARRAY AND PELVIC ARRAY CLAMP GOT CROSS THREADED AND NEED TO BE REPLACED. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373759 ↗
• MalfunctionSep 20, 2019Mechanical Problem; Misassembly by Users; Mechanical Problem; Misassembly by Users

  AFTER SURGERY WAS COMPLETED, TAKING APART THE FEMORAL ARRAY THE SCRUB TECH AND I NOTICED THE ARRAY ADAPTER AND FEMORAL ARRAY WERE CROSS-THREADED. CASE TYPE: TKA PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100864 ↗
• MalfunctionAug 9, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  ARRAY CLAMP AND ARRAY BROKE WHEN TIGHTENING. CASE TYPE: THA. SURGICAL DELAY: 2 MINUTES. UPDATE: "PATIENT WAS UNDER ANESTHESIA, IT HAPPENED INTRA OP. NO PARTS OF THE DEVICE WERE MISSING BEFORE THIS HAPPENED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879237 ↗
• MalfunctionJul 23, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  ARRAY ADAPTER BROKE OFF WHILE TIGHTENING CASE. TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816992 ↗
• MalfunctionJan 30, 2019Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  DURING CASE, WHERE THE 2 PIN CLAMP ATTACHES TO ARRAY ADAPTOR IT IS CROSS THREADED. IT WOULD NOT TIGHTEN THE ARRAY ENOUGH TO HOLD IT IN PLACE. CASE TYPE: PKA. PROVIDE MORE DETAIL: WHEN NOTICED HAS ALREADY FINISHED CUTS HOWEVER WEREN'T ABLE ASSESS LEG WITH TRIALS BECAUSE ARRAY WOULD NOT HOLD IN PLACE. SURGICAL DELAY: 10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288979 ↗
• MalfunctionOct 2, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  ADAPTER TIGHTENING BOLT BROKE OFF IN 3 PIN CLAMP. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7925641 ↗