OSCAR 3 1 (REF OHP2062SU)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18056099649803), received between Jul 4, 2019 and Mar 31, 2021 — classified as 3 injuries.

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

• InjuryMar 31, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PATIENT'S INFORMATION: (B)(6) YEARS, MALE, IN GOOD HEALTH CONDITION. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "REPETITION OF AN ERROR MESSAGE "POOR SIGNAL"; DIFFICULTY TO PROGRESS WITH THE CEMENTED PROBES; BROKEN PROBE". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 1 HOUR TOTAL DELAY; WRONG ROAD IN THE FEMUR. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. PRODUCT IS AVAILABLE FOR RETURN. ON MARCH 22, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE SALES REPRESENTATIVE: "THE COMPLAINT IS RELATED TO AN OSCAR GENERATOR CODE OS3000 SERIAL NUMBER (B)(4) (MFR REPORT 9680825-2021-00021) AND ONE PIERCER PROBE CODE OHP2062SU BATCH B1387807. DURING SURGERY, THE PROBE DID NOT RECOGNIZE THE BONE WHICH WAS PIERCED. THE PROBE IS NOT RETURNING (LOST BY THE HOSPITAL) WHILE THE GENERATOR IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594065 ↗
• InjuryOct 31, 2019Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) CLINIC, (B)(6), IRELAND. CASE DATE: (B)(6) 2019. SURGEON: MR. (B)(6). BODY PART TO WHICH DEVICE WAS APPLIED: HIP. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE EVENT DESCRIPTION: I WANTED TO GIVE YOU NOTICE THAT THE RECENT HIRE TO (B)(6) CLINIC OF THE OSCAR 2 EQUIPMENT RESULTED IN THE FAILURE OF A PROBE. THE HOSPITAL HAS RECORDED INTERNALLY THE FAILURE AS AN INCIDENT. THE PROBE FRACTURED AND WITH THE FRACTURED PART-PROBE NOT RETRIEVABLE FROM THE PATIENT DUE TO HEAVY BLOOD LOSS INCURRED DURING THE EARLY PART OF THE PROCEDURE (NOT DUE TO THE PROBE ISSUE). NO MORE TIME COULD BE AFFORDED TO SEARCH OUT THE PART-PROBE AND AS A RESULT IT WAS LEFT IN SITU. A CHECK WAS PERFORMED BY X-RAY TO LOCATE THE PART-PROBE. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: DETAILS NOT AVAILABLE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9260928 ↗
• InjuryJul 4, 2019Break; Break

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PATIENT INFORMATION: 79 YEAR-OLD, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: N/A. EVENT DESCRIPTION: "6MM PIERCER TIP BROKE OFF IN FEMUR AND COULD NOT BE RETRIEVED. 10 MINUTES WERE ADDED TO THE CASE DUE TO TRYING TO REMOVE THE BROKEN TIP. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: TIME SPENT ATTEMPTING TO REMOVE THE PROBE TIP. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITIONS: UNAVAILABLE. NOTE AND COMMENTS: PRO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8762414 ↗