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NA 112270Recalls & reported problems

Mako Surgical Corp. · 2-PIN CLAMP · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486015909), received between Jan 30, 2019 and Apr 24, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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

Device problems

  • Loose or Intermittent Connection1
  • Mechanical Problem1
  • Non Reproducible Results1
  • Output Problem1
  • Residue After Decontamination1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 24, 2023Residue After Decontamination; Residue After Decontamination

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16793603 ↗
  • MalfunctionJun 18, 2019Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

    DURING CUTTING FOR A TKA MADE ALL CUTS BESIDE DISTAL AND POSTERIOR CHAMFER CUT AND THE FEMORAL ARRAY BECAME VISIBLY LOOSE ON THE POSTERIOR CHAMFER CUT. SURGEON AND PA BELIEVE THAT THE FEMORAL ARRAY WAS PROPERLY TIGHTENED. BELIEVE MALFUNCTION IN 1/3 PARTS (FEMORAL ARRAY, SIDE CLAMP, PIN CLAMP) OR ALL PARTS. REQUESTING REPLACEMENT FOR ALL 3 PARTS. CASE WAS FINISHED ROBOTICALLY AND IMPLANTS FIT WELL. CASE TYPE: TKA. SURGICAL DELAY: APPROX. 16 - 30 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8706989 ↗
  • MalfunctionJan 30, 2019Loose or Intermittent Connection; Output Problem; Loose or Intermittent Connection; Output Problem

    DURING CASE, WHERE THE 2 PIN CLAMP ATTACHES TO ARRAY ADAPTOR "IT" IS CROSSTHREADED. 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 8288989 ↗

Other Orthopedic stereotaxic instrument devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.