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	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2019
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 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 surgery the arthrex screw ar-1360c broke.The broken fragment was not removed and will remain inside the patient.The surgery was completed successfully with a new device of the same part number.It was not necessary to change the surgical technique or to perform a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.It was observed that approximately 8.60 mm of the ar-1360c remained, with breakage noted at the third, distal-most thread of the biocomposite screw fragment.Due to the returned condition of the ar-1360c, dimensional analysis of the hex and screw threads could not be performed.This type of event is most likely the result of improper bone preparation, failure to insert the implant coaxial to the bone tunnel, prying or leveraging, or flexing the joint 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: 9327871
• Report Number: 1220246-2019-01417
• Device Sequence Number: 2272574
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/13/2020

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: 03/31/2020
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 10201178
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other