Orthofix External Fixation Screw (Pin) with Hydroxyapatite coating 1 (REF 99-60138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18032568861815), received between Jun 8, 2017 and Nov 20, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2020Fracture; Fracture

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: (B)(4). BATCH NUMBER: B1144376. QUANTITY: 1. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: NO RESPONSE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "OSTEOTITE BONE SCREW BROKE OFF DURING INSERTION. DOCTOR PREDRILLED WITH A 3.2MM BIT AND WAS MANUALLY INSERTING THE PIN USING A T HANDLE. THE PIN BROKE OFF FLUSH WITH THE BONE AND THE DOCTOR WAS NOT ABLE TO EXTRACT IT". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. 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. PRODUCT IS AVAILABLE FOR RETURN. THE EVENT SHOULD NOT BE NOTIFIED TO THE LOCAL COMPETENT AUTHORITY. PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. ON NOVEMBER 13, 2020, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONA

  Patient problems: Foreign Body In Patient

  MAUDE report 10873849 ↗
• InjuryJun 19, 2018Break; Entrapment of Device

  INFORMATION PROVIDED STATES THAT DURING THE APPLICATION OF THE EXTERNAL FIXATOR THE SURGEON PRE-DRILLED USING A 3.2MM DRILL BIT. THE 1ST SCREW BROKE WHILE BEING IMPLANTED IN THE TIBIA. THE 2ND BONE SCREW BROKE ONCE THE SCREW WAS COMPLETELY IN THE BONE AND BEING TIGHTENED DOWN. THE THREADED SECTION OF BOTH BONE SCREWS REMAIN IMPLANTED IN THE PATIENT'S TIBIA.

  Patient problems: Bone Fracture(s)

  MAUDE report 7616606 ↗
• InjuryJun 14, 2018Fracture; Fracture

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-60138 (OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM); BATCH NUMBER: V1382507 AND V1389095 (MFR REPORTS 9680825-2018-00047 AND 9680825-2018-00048 RESPECTIVELY); QUANTITY: 1 EACH; HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: OTHER; PATIENT INFORMATION: (B)(6) YEARS, FEMALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SURGERY WAS FOR APPLICATION OF THE TL HEX FIXATOR. DURING APPLICATION OF THE TRUE LOK HEX EXTERNAL FIXATOR DR. (B)(6) PRE DRILLED 3.2 DRILL BIT 1ST SCREW 99-60138 (LOT V1382507) 1IN CORTISIZED IT BROKE DURING THE DRILLING. THE 2ND BONE SCREW 99-60138 (LOT V1389095) BROKE ONCE THE SCREW WAS ALL THE WAY THROUGH THE BONE WHILE FASTENING IN IT SNAPPED OUT. INCREASED SURGERY BY 5 MINUTES. ADVERSE EFFECTS ON PATIENT LEFT WITH TWO BROKE SCREWS IN THE TIBIA. THE SURGERY WAS COMPLETED WITH THE DEVICE. NO X-RAYS OR OPERATIVE REPORTS ARE AVAILABLE. CASE TOOK PLACE AT (B)(6)'S HOSPITAL MED. ON (B)(

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7599892 ↗
• InjuryJun 8, 2017Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6), DATE OF INITIAL SURGERY: TO BE SUPPLIED. BODY PART TO WHICH DEVICE WAS APPLIED: NOT AVAILABLE. SURGERY DESCRIPTION: LENGTHENING. PATIENT'S INFORMATION: (B)(6) YEARS OLD, FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "(B)(6) FROM UNIVERSITY HOSPITAL (B)(6) HAS INFORMED ME THAT THERE HAS BEEN ONE HALF PIN AND ONE WIRE BREAKAGE WITH ONE OF HIS FEMALE PAEDIATRIC TLHEX FRAMES. THE PATIENT IS BEING TAKEN BACK TO THEATRE THIS FRIDAY (B)(6) TO HAVE THE BROKEN HALF PINS AND WIRES REPLACED WHICH I HAD SENT OUT FROM THE OFFICE YESTERDAY. THE (B)(6) IS OK ALTHOUGH HER REGENERATE IS DRIFTING A LITTLE INTO A NEW VALGUS DEFORMITY. FROM WHAT THE SURGEON HAS TOLD ME, THE DAMAGE HAS BEEN CAUSED BY THE PATIENT CATCHING HER FRAME ON HER BED." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF DISTRACTION/CORRECTION ACHIEVED. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: (B)(6) 2017. A MEDICAL INTERVENT

  Patient problems: No Code Available

  MAUDE report 6621570 ↗