OSCAR 3 1 (REF OHS2080SU)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 18056099649780), received between Jan 4, 2018 and May 27, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2024Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: MR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: NOT AVAILABLE - PATIENT'S INFORMATION: NOT AVAILABLE - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: WHILST USING THE DEVICE IN SURGERY THE END OF THE PROBE SNAPPED OFF INTO PATIENT'S FEMUR. UNABLE TO RETRIEVE FROM PATIENT. THE CONSULTANT COMPLETED AN INCIDENT REPORT (SAFEGUARD 296913) AND INFORMED THE PATIENT. THE REMAINING PRODUCT WITH THE SAME LOT NUMBER WERE REMOVED FROM THE SHELF (1XBOX). FURTHER INFORMATION RECEIVED: -NO FURTHER OPERATION WILL BE REQUIRED AND NO IMAGING IS AVAILABLE FOR THIS REPORT. -PATIENT IS DOING ALRIGHT - AWARE ABOUT BROKEN OSCAR BIT RETAINED IN HER FEMORAL CANAL. (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 19400353 ↗
• MalfunctionJan 15, 2024Mechanical Problem; Mechanical Problem

  ON JANUARY 4, 2024, ORTHOFIX SRL RECEIVED DIRECTLY FROM MHRA INFORMATION ABOUT AN ADVERSE INCIDENTS OCCURRED IN THE UK MARKET. A SUMMARY OF THE INFORMATION IS REPORTED BELOW: HOSPITAL NAME: (B)(6) HOSPITALS CONTACT NAME: (B)(6) REFERENCE NUMBER ASSIGNED BY MHRA FOR THIS INCIDENT: USER REPORT REF: 2023/011/022/501/007 [MHRA REF: 27601013-AICXML] DATE OF INCIDENT: ON (B)(6) 2023 NATURE OF INCIDENT: WHILE USING THE PROBE DURING SURGERY, FOR REMOVAL OF CEMENT OF THE FEMORAL CANAL, THE OSCAR3 UNIT HIGHLIGHTED AS WEAK FEEDBACK. AS THE SURGEON RETRIEVED THE PROBE FROM THE FEMORAL CANAL, IT WAS NOTED THE PROBE WAS BENT AND SUDDENLY BROKE IN TWO PIECES. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18510389 ↗
• InjuryDec 4, 2018Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) . SURGEON'S NAME: DR. (B)(6) . DATE OF SURGERY: (B)(6) 2018 BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. PATIENT INFORMATION: 63 YEAROLD, FEMALE, PREVIOUS HEALTH CONDITION: INTERVENTION ON PTH. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: 63YEAROLD PATIENT MANAGED FOR PTH REVISION FOR STEM LOOSENING. THE ABLATION OF THE CEMENT IS CARRIED OUT WITH THE OSCAR ABLATION SYSTEM FROM ORTHOFIX. THE DEVICE "SCRAPPER PROBE" BROKE IN THE FEMUR OF THE PATIENT. THE HEAD OF THE DEVICE REMAINED STUCK IN THE FEMORAL SHAFT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LONGER INTERVENTION TIME. RISK OF HAVING TO PERFORM A FEMOROTOMY IF THE HEAD OF THE DEVICE COULD NOT BE REMOVED. THE SURGERY WAS NOT COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: LONGER INTERVENTION TIME. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE

  Patient problems: No Code Available

  MAUDE report 8127902 ↗
• InjuryMar 21, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: "TWO PROBES USED WITHIN PATIENT FEMUR SNAPPED IN HALF DURING THE PROCESS, SURGEON HAS PROVIDED PHOTOS WHICH WILL BE ATTACHED WITH COMPLAINT FORM. SURGERY DELAYED BY 30MINS. WAITING ON FURTHER INFORMATION FROM HOSPITAL REGARDING COLLECTION OF PROBES. AS YET THE MODEL NUMBER AND SERIAL NUMBER HAVE NOT BEEN OBTAINED". ON (B)(6) 2018, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING INFORMATION FROM (B)(6): HOSPITAL NAME: (B)(6) HOSPITAL, CONSULTANT IN CHARGE: (B)(6), INCIDENT NUMBER: (B)(4), TYPE OF INJURY: NONE, CATALOGUE NUMBER: OHS2080SU, LOT OR BATCH NUMBER: B1116376, DATE OF MANUFACTURE: 21 JUN 2017, EXPIRY DATE: 21 MAY 2022, DATE OF INCIDENT: (B)(6) 2018. DETAILS OF INCIDENT: WHILE SURGEON WAS CLEARING THE CEMENT FROM FEMUR USING OSCAR 2, 8MM SCRAPER SINGLE USE PROBE SUDDENLY BROKE AND GOT STUCK INSIDE FEMUR. USED NEW PROBE SAME DESCRIPTION AND CONTINUE TO CLEAR THE CEMENT BUT SECOND PROBE ALSO BROKE AGAIN. DETAILS OF INJURY: OSCAR PROBE WAS BROKEN INSIDE THE FEMUR, THE BROKEN TIP WAS RETRIEVED. NO HARM CAUSED TO THE PATIENT. IT CAUSED STRESS TO THE SURGEON AND SCRUB NURSE. ACTION TAKEN: DISCONTINUED USING THE PROBE. (

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356643 ↗
• InjuryJan 4, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY (B)(6) INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL. - CONSULTANT IN CHARGE: MR (B)(6). - INCIDENT NUMBER: (B)(4). - TYPE OF INJURY: NONE. - DATE OF INCIDENT: (B)(6) 2017. - DETAILS OF INCIDENT: WHEN THE CONSULTANT SURGEON WAS USING THE OSCAR PROBE TO REMOVE ORTHOPAEDIC BONE CEMENT FROM THE FEMUR THE PROBE BROKE OFF INSIDE THE FEMUR. THIS WAS WITH NO GREAT PRESSURE OR FORCE. THE BROKEN PIECE WAS RETRIEVED FROM THE FEMUR, REMOVED FROM THE SURGICAL FIELD AND REPORTED BY THE TEAM LEADER. - DETAILS OF INJURY: NO INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163215 ↗