MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM INTERFERENCE SCREW, TAPERED TIP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COM INTERFERENCE SCREW, TAPERED TIP
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2021
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 the device broke inside the patient when screwing it in.The broken part was retrieved from the patient.There was no harm or adverse event for patient, operator or third party reported.The knee arthroscopy 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.Update (b)(6) 2021: it was confirmed that no broken parts remained in the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1360c biocomposite screw (no batch indicator present) was received for investigation.Visual inspection identified that the ar-1360c broke at the sixth distal-most screw from the hex, with fragments visible at the breakage site.It was identified that approximately 15.3mm of the biocomposite screw remained.It was noted that the method used to prep the bone during the procedure, as well as the bone quality encountered, were not recorded.As such, the observed condition of the returned device is most likely the result of improper bone preparation, off-axis insertion, and/or prying/leveraging the screw during insertion.

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11393406
• Report Number: 1220246-2021-02638
• Device Sequence Number: 3117650
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 11011811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1