MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTER-FERENCE SCRW
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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 reconstruction surgery the device broke inside the patient when tightening it after a few turns.The broken piece was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.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 confirmed.One unpackaged ar-5028c-08 biocomposite interference screw was received for investigation.It was identified using digital caliper id:011 that the returned screw broke into two fragments, with one piece measuring approximately 7.33mm, and the other piece measuring approximately 15.81mm.It was noted that the method of bone preparation employed during the procedure, as well as the bone quality encountered, were not reported.As such, this event is most likely the result of improper bone preparation, off-axis insertion, and/or through prying/leveraging the screw during insertion.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12196077
• Report Number: 1220246-2021-03396
• Device Sequence Number: 3682619
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071176
• 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): 09/15/2021

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: 03/31/2024
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10784772
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/27/2021
• Supplement Date Received by Manufacturer: 06/27/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/15/2021
• Patient Sequence Number: 1