MAUDE Adverse Event Report: ARTHREX, INC. 10X 30MM BC IF SCRW, VENTED; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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 an anterior cruciate ligament surgery while implanting the screw it cracked and broke in two when the surgeon removed it.The surgeon was able to retrieve the implant and the debris out of the patient.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
One unpackaged ar-4030c-10 (no batch indicator present) was received for investigation.It was identified using digital caliper id: (b)(4) that approximately 24.63mm of the biocomposite screw remained.Breakage and cracks were present across the three distal-most threads.The method used to prepare the bone during the procedure, as well as the bone quality provided, were not provided.As such, this event is most likely the result of improper bone preparation and/or user-applied mechanical forces via prying/leveraging during insertion.

• Brand Name: 10X 30MM 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: 12467121
• Report Number: 1220246-2021-03639
• Device Sequence Number: 14399777
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: 00888867277670
• 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): 10/06/2021

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: 10/31/2024
• Device Model Number: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 12141957
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1