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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
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.
Event or Problem Description
It was reported that during a patellar tendon allograft anterior cruciate ligament reconstruction surgery the device (ar-4020c-09, lot 11764659) broke inside the patient in the middle of implanting in a 9 mm diameter tibial tunnel.The surgeon used a tap before inserting the device as a bone tendon bone graft.There was no harm 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.
Additional Manufacturer Narrative
Complaint is confirmed.No device was returned for investigation, however a picture of the screw used in the procedure was received.Based on the image provided, it can be seen that the screw broke approximately after the third thread from the proximal end.As the device was not returned for investigation, the cause cannot be determined.

• 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: 11599597
• Report Number: 1220246-2021-02812
• Device Sequence Number: 19829572
• Product Code: MAI
• UDI-Device Identifier: 00888867276970
• UDI-Public: 00888867276970
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/17/2021

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 Expiration Date: 08/31/2024
• Device Model Number: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Device Lot Number: 11764659
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1