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

Model Number	SCREW, CANCELLOUS
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that after an initial successful surgery which was performed on (b)(6) 2019 a patient complaint about pain nearby the osteotomy.A ct and y-ray was performed and confirmed that the screw heads were out of the plate and therefore found to be broken.A revision high tibial osteotomy was successfully performed on (b)(6) 2020 to retrieve the screws out of the patient.
Event or Problem Description
It was reported that after an initial successful surgery which was performed on (b)(6)2019 a patient complaint about pain nearby the osteotomy.A ct and x-ray was performed and confirmed that the screw heads were out of the plate and therefore found to be broken.A revision high tibial osteotomy was successfully performed on (b)(6) 2020 to retrieve the screws out of the patient.Update 27-jul-2020: further information were provided that the surgeon took out of the plate and did not implanted a new one as he thought the (partial) consolidation was already there.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the ar-13280-50 screw was fractured as well as two other cancellous screws.The other two fractured screws were unable to be identified due to the fractured state of the devices.The three intact screws were able to be identified through digital caliper measurements as two ar-13280-40 and one ar-13280-45.These screws were intact and did not reveal any damage or malfunction.The base plate showed signs of use but no damage or malfunction as well.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is excessive mechanical forces while implanted in the body.This follow up submission also contains additional information in section b5, event description.

• Brand Name: SCREW, CANCELLOUS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10307910
• Report Number: 1220246-2020-01958
• Device Sequence Number: 952236
• Product Code: HRS
• UDI-Device Identifier: 00888867010567
• UDI-Public: 00888867010567
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-50
• Device Lot Number: 10311150
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other