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	Foreign Body In Patient (2687)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has 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 an anterior cruciate ligament surgery when inserting the biocomposite screw the tip broke off and was left in the joint.The surgeon was not able to retrieve the broken piece.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.Update 29-jan-2019: the broken fragment is screwed tight in the joint.It cannot move.
Additional Manufacturer Narrative
Complaint confirmed.The tip of the implant is damaged and appears to be missing material.The 2nd thread was found to be damaged on the outside.The most likely cause of failure is improper bone preparation, not inserting the implant co-axial to the bone tunnel and/or prying and leveraging the device.

• 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: 8344600
• Report Number: 1220246-2019-00903
• Device Sequence Number: 1599147
• Product Code: MAI
• UDI-Device Identifier: 00888867035324
• UDI-Public: 00888867035324
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-08
• Device Lot Number: 10218626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other