Orthofix External Fixation Screw (Pin) with Hydroxyapatite coating 1 (REF 99-SS60627)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18032568039306), received between Jul 19, 2018 and Jul 20, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 18, 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.

• MalfunctionJul 20, 2022Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-SS60627. BATCH NUMBER: B1752654. HOSPITAL NAME: (B)(6). BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "BONE SCREW GOT BROKEN WHEN INSTALLING AN EXTERNAL FIXATOR. THE PART COULD NOT BE EXTRACTED FROM LEFT TIBIA OF THE PATIENT". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS). THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE . A REPLACEMENT DEVICE OF SAME MODEL WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. PRODUCT IS AVAILABLE FOR RETURN. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15063451 ↗
• InjuryJul 19, 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; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: (B)(6) YEAR-OLD, FEMALE, PREVIOUS HEALTH CONDITION: GOOD. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: BEFORE DEVICE REMOVAL, 2 PROXIMAL SCREWS BROKE ON THE BONE. SURGEON TAKE THE FRAME OFF, BECAUSE THE PATIENT HAS A LOT OF PAIN, SO HE PUT A PEDIATRIC RAIL IN ORDER TO WAIT FOR FEW WEEKS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. AN ADDITIONAL SURGERY WAS REQUIRED. FOLLOWING DEVICE FAILURE: PERFORMED END OF (B)(6). A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE (RECEIVED BY ORTHOFIX (B)(4) ON 28 JUNE 2018). FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 1 JULY 2018: DATE OF THE INITIAL SURGERY AND DATE OF THE ADDITIONAL SURGERY WHEN THE FIXATOR WAS CHANGED WITH A PAEDIATRIC RAIL INITIAL SURGERY: (B)(6) WAS T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7701675 ↗
• InjuryJul 19, 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: NA. - SURGERY DESCRIPTION: CORRECTION. - PATIENT INFORMATION: 19 YEAR-OLD, FEMALE, WEIGHT 45 KG., HEIGHT 160 CM, PREVIOUS HEALTH. CONDITION: GOOD. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: BEFORE DEVICE REMOVAL, 2 PROXIMAL SCREWS BROKE ON THE BONE. SURGEON TAKE THE FRAME OFF, BECAUSE THE PATIENT HAS A LOT OF PAIN, SO HE PUT A PEDIATRIC RAIL IN ORDER TO WAIT FOR FEW WEEKS. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: PERFORMED END OF APRIL/BEGINNING OF MAY. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE AVAILABLE (RECEIVED BY ORTHOFIX SRL ON 28 JUNE 2018). - PATIENT CURRENT HEALTH CONDITION: NA. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 1 JUL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7701674 ↗