MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 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	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament ligamentoplasty surgery the head of the device became detached from the body at the time of screwing.All broken parts were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (ar-4020c-06).It was not necessary to switch the surgical technique or do a second surgery.
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
Complaint confirmed.Upon visual inspection it was noted that part of the device is missing.Only the head of the anchor was returned for evaluation.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: Ø9X 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13995364
• Report Number: 1220246-2022-04706
• Device Sequence Number: 14751299
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 12/31/2024
• Device Model Number: Ø9X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-09
• Device Lot Number: 12598190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown