MAUDE Adverse Event Report: ARTHREX, INC. 9X 20MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø9X 20MM BC IF SCRW, VENTED
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
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 during knee arthroscopy surgery the screw broke off while inserting.The broken off piece has not been retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, (b)(6) 2021 received further information that the screw is secure inside the femur bone and cannot be moved/ is not loosening.
Additional Manufacturer Narrative
Complaint confirmed, a broken fragment of ar-4020c-09 was received.The fragment measures approximately 1 cm long, and is warped.The device could not be measured due to the damage and biohazard residue found.The cause of the event is undetermined, however likely causes include improper bone prep; misaligned insertion; prying/leveraging the device during insertion and/or shallow driver engagement depth.

• Brand Name: 9X 20MM BC IF SCRW, VENTED
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540056
• Report Number: 1220246-2021-03696
• Device Sequence Number: 14296125
• Product Code: MAI
• UDI-Device Identifier: 00888867276970
• UDI-Public: 00888867276970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180662
• 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): 10/20/2021

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 Model Number: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1