MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS; PLATE, FIXATION, BONE

Model Number	SCREW, CANCELLOUS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken during the removal of the plate and the screws one year after a high tibial osteotomy surgery.The screws and the plate were discarded and the remaining broken parts were not removed out of the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update 25-nov-2021: it was confirmed that the screws were already broken before the surgeon tried to remove them.The surgery was no revision, as the defect of the devices was not seen on the x-rays before surgery.The correction of the high tibial osteotomy was still fine.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device was broken during the removal of the plate and the screws one year after a high tibial osteotomy surgery.The screws and the plate were discarded and the remaining broken parts were not removed out of the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update 25-nov-2021: it was confirmed that the screws were already broken before the surgeon tried to remove them.The surgery was no revision, as the defect of the devices was not seen on the x-rays before surgery.The correction of the high tibial osteotomy was still fine.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photos, which identify that the cancellous screw had broken.However, without receipt of the screw for evaluation, no dimensions were able to be assessed and no further analysis on the devices involved in the event could be conducted.The cause remains undetermined.

• Brand Name: SCREW, CANCELLOUS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12983575
• Report Number: 1220246-2021-04085
• Device Sequence Number: 4582634
• Product Code: HRS
• UDI-Device Identifier: 00888867010598
• UDI-Public: 00888867010598
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-65
• Device Lot Number: 10778841
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/24/2022
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown