MAUDE Adverse Event Report: ORTHOFIX CETRA; 4.0MM X 16MM PRIMARY SEMI-CONSTRAINED SELF DRILLING SCREW

Model Number	19-6516
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not returning for investigation.Rep stated that the two inferior screws failed locking mechanism was removed and then discarded per banner policy.The 4-level plate assembly (pn:19-0478 ln: e12) was not returned for investigation.However, based on the x-ray image provided it can be confirmed that a screw is backing out and the locking tab has pulled away from the plate.It is possible the locking tab could have been subjected to overload by leaving the screws proud causing the locking tab to stress at fillet which is a weaker cross section of the design.However, with the limited available information and the device not returned for examination, the root cause of the product complaint cannot be determined.A review of the product dhr showed that all inspections met design specifications.A review of ncmr databases did not reveal any nonconformances related to this investigation.
Event or Problem Description
It was reported that the patient went in for a 6 week follow up.Patient hardware was intact.At 4 months a locking mechanism failed.Two inferior screws and failed locking mechanism were removed and discarded per banner hospital policy.Device not returning.A revision was performed on (b)(6) 2024.No known non-union.No issues intraoperatively.Patient had no fall or any acute injury.
Additional Manufacturer Narrative
Device is not returning for investigation.Rep stated that the two inferior screws failed locking mechanism was removed and then discarded per banner policy.The 4-level plate assembly (pn:19-0478 ln: e12) was not returned for investigation.However, based on the x-ray image provided it can be confirmed that a screw is backing out and the locking tab has pulled away from the plate.It is possible the locking tab could have been subjected to overload by leaving the screws proud causing the locking tab to stress at fillet which is a weaker cross section of the design.However, with the limited available information and the device not returned for examination, the root cause of the product complaint cannot be determined.A review of the product dhr showed that all inspections met design specifications.A review of ncmr databases did not reveal any nonconformance's related to this investigation.
Event or Problem Description
It was reported that the patient went in for a 6 week follow up.Patient hardware was intact.At 4 months a locking mechanism failed.Two inferior screws and failed locking mechanism were removed and discarded per banner hospital policy.Device not returning.A revision was performed on (b)(6)2024.No known non-union.No issues intraoperatively.Patient had no fall or any accute injury.Rev.1 correct component code to 568 screws.

• Brand Name: CETRA
• Common Device Name: 4.0MM X 16MM PRIMARY SEMI-CONSTRAINED SELF DRILLING SCREW
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano pkwy; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056
• MDR Report Key: 20249342
• Report Number: 2183449-2024-00014
• Device Sequence Number: 20658305
• Product Code: KWQ
• UDI-Device Identifier: 18257200134946
• UDI-Public: 18257200134946
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 19-6516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male